Trial Outcomes & Findings for Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery (NCT NCT03325972)
NCT ID: NCT03325972
Last Updated: 2023-06-05
Results Overview
Amount of morphine administered during the 48 hours following surgery.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
Up to 48 Hours Post-Surgery (Day 2)
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
IV Dexmedetomidine
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
|
Overall Study
COMPLETED
|
18
|
13
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Baseline characteristics by cohort
| Measure |
IV Dexmedetomidine
n=33 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=31 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 Hours Post-Surgery (Day 2)Amount of morphine administered during the 48 hours following surgery.
Outcome measures
| Measure |
IV Dexmedetomidine
n=33 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=30 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Morphine Equivalents Used During the First 48 Hours Post-Surgery
|
180 morphine milligram equivalent (MME)
Interval 120.0 to 309.5
|
142.5 morphine milligram equivalent (MME)
Interval 76.5 to 211.5
|
SECONDARY outcome
Timeframe: 48 Hours Post-Surgery (Day 2)The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.'
Outcome measures
| Measure |
IV Dexmedetomidine
n=32 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=30 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery
|
7.27 score on a scale
Standard Deviation 1.96
|
6.53 score on a scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Week 6The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.'
Outcome measures
| Measure |
IV Dexmedetomidine
n=26 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=19 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery
|
3 score on a scale
Standard Deviation 2.61
|
3.26 score on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Up to Week 6Amount of morphine administered during the 6 weeks following surgery.
Outcome measures
| Measure |
IV Dexmedetomidine
n=22 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=18 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Morphine Equivalents Used at 6 Weeks Post-Surgery
|
0 morphine milligram equivalent (MME)
Interval 0.0 to 6.25
|
0 morphine milligram equivalent (MME)
Interval 0.0 to 1.25
|
SECONDARY outcome
Timeframe: From beginning up to end of surgery (Day 0 - typically 1 to 3 hours)The intraoperative period begins when the patient is transferred to the operating room table and ends with the transfer of a patient to the Post Anesthesia Care Unit (PACU).
Outcome measures
| Measure |
IV Dexmedetomidine
n=33 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=31 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Number of Participants Requiring Pressor Use During Intraoperative Period
|
25 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 48 Hours Post-Surgery (Day 2)Outcome measures
| Measure |
IV Dexmedetomidine
n=33 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=30 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)Outcome measures
| Measure |
IV Dexmedetomidine
n=32 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=30 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Length of PACU Stay
|
172 minutes
Standard Deviation 90.24
|
152 minutes
Standard Deviation 58.77
|
SECONDARY outcome
Timeframe: From admission up to discharge (Up to 6 Weeks)Outcome measures
| Measure |
IV Dexmedetomidine
n=33 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=31 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Length of Hospital Stay
|
5.89 Days
Standard Deviation 2.55
|
5.03 Days
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: 48 Hours Post-Surgery (Day 2)The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery.
Outcome measures
| Measure |
IV Dexmedetomidine
n=32 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=30 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery
|
90.73 score on a scale
Standard Deviation 16.72
|
89.3 score on a scale
Standard Deviation 21.03
|
SECONDARY outcome
Timeframe: Week 6The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery.
Outcome measures
| Measure |
IV Dexmedetomidine
n=24 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=18 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery
|
115.5 score on a scale
Standard Deviation 16.91
|
120.67 score on a scale
Standard Deviation 16.57
|
SECONDARY outcome
Timeframe: 48 Hours Post-Surgery (Day 2)The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale (VAS) item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain. The SF-MPQ is administered on postoperative days 1 and 2.
Outcome measures
| Measure |
IV Dexmedetomidine
n=31 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=30 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery
|
27.9 score on a scale
Standard Deviation 8.9
|
25.5 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Week 6The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain.
Outcome measures
| Measure |
IV Dexmedetomidine
n=26 Participants
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=19 Participants
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery
|
15.2 score on a scale
Standard Deviation 23.1
|
12.2 score on a scale
Standard Deviation 11.4
|
Adverse Events
IV Dexmedetomidine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Dexmedetomidine
n=33 participants at risk
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
Placebo
n=31 participants at risk
saline placebo
Placebo Saline: Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.0%
1/33 • 6 weeks following last administration of study treatment
At each contact with the participant, the investigator requested information on adverse events by specific questioning and, as appropriate, by examination.
|
3.2%
1/31 • 6 weeks following last administration of study treatment
At each contact with the participant, the investigator requested information on adverse events by specific questioning and, as appropriate, by examination.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/33 • 6 weeks following last administration of study treatment
At each contact with the participant, the investigator requested information on adverse events by specific questioning and, as appropriate, by examination.
|
3.2%
1/31 • 6 weeks following last administration of study treatment
At each contact with the participant, the investigator requested information on adverse events by specific questioning and, as appropriate, by examination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place