Trial Outcomes & Findings for Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy (NCT NCT03435003)
NCT ID: NCT03435003
Last Updated: 2024-02-14
Results Overview
The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
up to 1 week post-operation (up to 2 weeks from baseline)
Results posted on
2024-02-14
Participant Flow
Participant milestones
| Measure |
Intervention Arm
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=41 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=42 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
43 years
STANDARD_DEVIATION 13 • n=4 Participants
|
42.2 years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Previous history of postoperative nausea and vomiting (PONV)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Weight
|
292 lbs
STANDARD_DEVIATION 52 • n=93 Participants
|
293 lbs
STANDARD_DEVIATION 61 • n=4 Participants
|
292.5 lbs
STANDARD_DEVIATION 56.4 • n=27 Participants
|
|
BMI
|
47.3 kg/m2
STANDARD_DEVIATION 6.4 • n=93 Participants
|
46.4 kg/m2
STANDARD_DEVIATION 7.5 • n=4 Participants
|
46.8 kg/m2
STANDARD_DEVIATION 6.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: up to 1 week post-operation (up to 2 weeks from baseline)The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
Outcome measures
| Measure |
Intervention Arm
n=41 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=42 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
Number of Participants With PONV-related Delay of Hospital Discharge
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeksThe severity of PONV will be measured using a visual analogue scale. \[0-10\] The higher the value, the worse the outcome.
Outcome measures
| Measure |
Intervention Arm
n=39 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=40 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
Baseline
|
0.12 score on a scale
Standard Deviation 0.56
|
0.10 score on a scale
Standard Deviation 0.43
|
|
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
1 hr
|
2.29 score on a scale
Standard Deviation 2.86
|
3.68 score on a scale
Standard Deviation 3.45
|
|
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
4 hr
|
1.46 score on a scale
Standard Deviation 1.82
|
2.76 score on a scale
Standard Deviation 2.97
|
|
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
12 hr
|
0.69 score on a scale
Standard Deviation 1.47
|
2.19 score on a scale
Standard Deviation 2.63
|
|
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
24 hr
|
0.44 score on a scale
Standard Deviation 1.16
|
1.80 score on a scale
Standard Deviation 2.89
|
|
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
3 week
|
0.15 score on a scale
Standard Deviation 0.43
|
0.58 score on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeksThe Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points . The scoring of each item on the Rhodes Index is as follows: 0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named "experience," "occurrence," and "distress" . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=42 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
Severity of PONV Measured Using the Rhodes Index
Baseline
|
0.08 score on a scale
Interval 0.0 to 3.0
|
0.19 score on a scale
Interval 0.0 to 4.0
|
|
Severity of PONV Measured Using the Rhodes Index
12 hr
|
1.79 score on a scale
Interval 0.0 to 8.0
|
6.17 score on a scale
Interval 0.0 to 24.0
|
|
Severity of PONV Measured Using the Rhodes Index
24 hr
|
0.69 score on a scale
Interval 0.0 to 6.0
|
5.26 score on a scale
Interval 0.0 to 23.0
|
|
Severity of PONV Measured Using the Rhodes Index
3 weeks
|
0.13 score on a scale
Interval 0.0 to 3.0
|
1.42 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hours and 3 weeksThe quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.
Outcome measures
| Measure |
Intervention Arm
n=40 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=42 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
24 hr
|
120.59 score on a scale
Interval 86.0 to 147.0
|
109.29 score on a scale
Interval 59.0 to 146.0
|
|
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
3 weeks
|
137.53 score on a scale
Interval 78.0 to 150.0
|
130.64 score on a scale
Interval 61.0 to 150.0
|
SECONDARY outcome
Timeframe: Baseline, 24 hours and 3 weeksThe GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Outcome measures
| Measure |
Intervention Arm
n=41 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=42 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
Baseline
|
108.34 score on a scale
Standard Deviation 12.49
|
107.52 score on a scale
Standard Deviation 13.35
|
|
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
3 Weeks
|
100.71 score on a scale
Standard Deviation 20.60
|
98.03 score on a scale
Standard Deviation 25.22
|
SECONDARY outcome
Timeframe: Baseline, 24 hours and 3 weeksEQ-5D Descriptive System: Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Levels: Each dimension has 5 severity levels: 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. Extreme problems Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
Outcome measures
| Measure |
Intervention Arm
n=41 Participants
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
Control Arm
n=42 Participants
A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
|
|---|---|---|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Usual activities · Slight
|
13 Participants
|
9 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Usual activities · Moderate
|
5 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Usual activities · Severe
|
1 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Usual activities · Unable
|
2 Participants
|
5 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Usual activities · None
|
11 Participants
|
15 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Self-care · Severe
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Self-care · Not Reported
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Usual activities · None
|
29 Participants
|
29 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Usual activities · Slight
|
7 Participants
|
8 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Usual activities · Moderate
|
3 Participants
|
5 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Usual activities · Severe
|
2 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Usual activities · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Usual activities · Not Reported
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Anxiety/depression · None
|
26 Participants
|
29 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Anxiety/depression · Slight
|
11 Participants
|
10 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Anxiety/depression · Moderate
|
4 Participants
|
2 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Anxiety/depression · Severe
|
0 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Anxiety/depression · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Anxiety/depression · Not Reported
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Mobility · None
|
36 Participants
|
29 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Mobility · Slight
|
2 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Mobility · Moderate
|
2 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Mobility · Severe
|
1 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Mobility · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Mobility · Not Reported
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Pain/discomfort · None
|
24 Participants
|
20 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Pain/discomfort · Slight
|
12 Participants
|
13 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Pain/discomfort · Moderate
|
4 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Pain/discomfort · Severe
|
0 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Pain/discomfort · Unable
|
1 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Pain/discomfort · Not Reported
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Self-care · None
|
37 Participants
|
38 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Self-care · Slight
|
2 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Self-care · Moderate
|
1 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Self-care · Severe
|
1 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Baseline: Self-care · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Usual activities · Not Reported
|
9 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Anxiety/depression · None
|
29 Participants
|
25 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Anxiety/depression · Slight
|
3 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Anxiety/depression · Moderate
|
0 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Anxiety/depression · Severe
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Anxiety/depression · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Anxiety/depression · Not Reported
|
9 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Mobility · None
|
25 Participants
|
27 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Mobility · Slight
|
6 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Mobility · Moderate
|
1 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Mobility · Severe
|
0 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Mobility · Unable
|
0 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Mobility · Not Reported
|
9 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Pain/discomfort · None
|
4 Participants
|
4 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Pain/discomfort · Slight
|
16 Participants
|
16 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Pain/discomfort · Moderate
|
12 Participants
|
14 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Pain/discomfort · Severe
|
0 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Pain/discomfort · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Pain/discomfort · Not Reported
|
9 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Self-care · None
|
22 Participants
|
26 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Self-care · Slight
|
5 Participants
|
4 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Self-care · Moderate
|
4 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Self-care · Severe
|
0 Participants
|
2 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Self-care · Unable
|
1 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
24 h: Self-care · Not Reported
|
9 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Usual activities · None
|
37 Participants
|
25 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Usual activities · Slight
|
2 Participants
|
8 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Usual activities · Moderate
|
0 Participants
|
3 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Usual activities · Severe
|
1 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Usual activities · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Usual activities · Not Reported
|
1 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Anxiety/depression · None
|
33 Participants
|
28 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Anxiety/depression · Slight
|
6 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Anxiety/depression · Moderate
|
1 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Anxiety/depression · Severe
|
0 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Anxiety/depression · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Anxiety/depression · Not Reported
|
1 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Mobility · None
|
37 Participants
|
27 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Mobility · Slight
|
1 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Mobility · Moderate
|
2 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Mobility · Severe
|
0 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Mobility · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Mobility · Not Reported
|
1 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Pain/discomfort · None
|
23 Participants
|
16 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Pain/discomfort · Slight
|
14 Participants
|
13 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Pain/discomfort · Moderate
|
2 Participants
|
6 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Pain/discomfort · Severe
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Pain/discomfort · Unable
|
1 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Pain/discomfort · Not Reported
|
1 Participants
|
7 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Self-care · None
|
38 Participants
|
31 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Self-care · Slight
|
1 Participants
|
4 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Self-care · Moderate
|
1 Participants
|
1 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Self-care · Unable
|
0 Participants
|
0 Participants
|
|
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
3 weeks: Self-care · Not Reported
|
1 Participants
|
6 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place