Trial Outcomes & Findings for Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery (NCT NCT03850093)
NCT ID: NCT03850093
Last Updated: 2020-02-07
Results Overview
according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding. 1. Slight bleeding- no blood suctioning required. 2. Slight bleeding- occasional blood suctioning required. 3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation. 4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation. 5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end
Results posted on
2020-02-07
Participant Flow
66 patients who underwent endoscopic sinus surgery were eligible for the study
Participant milestones
| Measure |
Gabapentin Group (Group G)
21 patients completed the study and were considered for statistical analysis
|
Bisoprolol Group (Group B)
22 patients were allocated to group B, completed the study and were considered for statistical analysis
|
Control Group (Group C)
17 patients completed the study and were considered for statistical analysis
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
19
|
|
Overall Study
COMPLETED
|
21
|
22
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Gabapentin Group (Group G)
21 patients completed the study and were considered for statistical analysis
|
Bisoprolol Group (Group B)
22 patients were allocated to group B, completed the study and were considered for statistical analysis
|
Control Group (Group C)
17 patients completed the study and were considered for statistical analysis
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
30.5 years
STANDARD_DEVIATION 6.6 • n=22 Participants
|
28.6 years
STANDARD_DEVIATION 5.1 • n=17 Participants
|
27.93 years
STANDARD_DEVIATION 6.97 • n=60 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=21 Participants
|
9 Participants
n=22 Participants
|
6 Participants
n=17 Participants
|
23 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=21 Participants
|
13 Participants
n=22 Participants
|
11 Participants
n=17 Participants
|
37 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
weight, continuous
|
87.1 kilograms
STANDARD_DEVIATION 1.1 • n=21 Participants • patients' withdrawal from the study
|
87.9 kilograms
STANDARD_DEVIATION 11.9 • n=22 Participants • patients' withdrawal from the study
|
84.5 kilograms
STANDARD_DEVIATION 11.5 • n=17 Participants • patients' withdrawal from the study
|
85.62 kilograms
STANDARD_DEVIATION 11.5 • n=60 Participants • patients' withdrawal from the study
|
|
indication for surgery, categorical)
polyp
|
11 Participants
n=21 Participants • 3 patients were withdrawn from the study
|
13 Participants
n=22 Participants • 3 patients were withdrawn from the study
|
10 Participants
n=17 Participants • 3 patients were withdrawn from the study
|
34 Participants
n=60 Participants • 3 patients were withdrawn from the study
|
|
indication for surgery, categorical)
sinusitis
|
10 Participants
n=21 Participants • 3 patients were withdrawn from the study
|
9 Participants
n=22 Participants • 3 patients were withdrawn from the study
|
7 Participants
n=17 Participants • 3 patients were withdrawn from the study
|
26 Participants
n=60 Participants • 3 patients were withdrawn from the study
|
|
mean arterial blood pressure (MAP), continuous
|
96.6 mmHg
STANDARD_DEVIATION 7.5 • n=21 Participants • 3 patients were withdrawn from the study
|
92.9 mmHg
STANDARD_DEVIATION 7.4 • n=22 Participants • 3 patients were withdrawn from the study
|
88.2 mmHg
STANDARD_DEVIATION 11.7 • n=17 Participants • 3 patients were withdrawn from the study
|
93.4 mmHg
STANDARD_DEVIATION 9.7 • n=60 Participants • 3 patients were withdrawn from the study
|
|
heart rate (HR), continuous
|
91.1 beats/minute
STANDARD_DEVIATION 11.6 • n=21 Participants • 3 patients were withdrawn from the study
|
82.9 beats/minute
STANDARD_DEVIATION 6.4 • n=22 Participants • 3 patients were withdrawn from the study
|
83.8 beats/minute
STANDARD_DEVIATION 14.8 • n=17 Participants • 3 patients were withdrawn from the study
|
86.7 beats/minute
STANDARD_DEVIATION 11.98 • n=60 Participants • 3 patients were withdrawn from the study
|
|
side of surgery
bilateral
|
14 Participants
n=21 Participants • 3 patients were withdrawn from the study
|
11 Participants
n=22 Participants • 3 patients were withdrawn from the study
|
9 Participants
n=17 Participants • 3 patients were withdrawn from the study
|
34 Participants
n=60 Participants • 3 patients were withdrawn from the study
|
|
side of surgery
unilateral
|
7 Participants
n=21 Participants • 3 patients were withdrawn from the study
|
11 Participants
n=22 Participants • 3 patients were withdrawn from the study
|
8 Participants
n=17 Participants • 3 patients were withdrawn from the study
|
26 Participants
n=60 Participants • 3 patients were withdrawn from the study
|
PRIMARY outcome
Timeframe: scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the endaccording to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding. 1. Slight bleeding- no blood suctioning required. 2. Slight bleeding- occasional blood suctioning required. 3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation. 4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation. 5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Changes in Surgical Field Visibility
15 minutes
|
2 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Changes in Surgical Field Visibility
30 minutes
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Changes in Surgical Field Visibility
60 minutes
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
3 score on a scale
Interval 3.0 to 4.0
|
|
Changes in Surgical Field Visibility
90 minutes
|
1 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
3 score on a scale
Interval 2.0 to 3.0
|
|
Changes in Surgical Field Visibility
45 minutes
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 2.0 to 3.0
|
|
Changes in Surgical Field Visibility
75 minutes
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 2.0 to 3.0
|
|
Changes in Surgical Field Visibility
105 minutes
|
1 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 2.0 to 3.0
|
PRIMARY outcome
Timeframe: at the end of surgerytotal intraoperative blood loss (mL)
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Blood Loss
|
20 mL
Interval 10.0 to 40.0
|
20 mL
Interval 10.0 to 30.0
|
80 mL
Interval 30.0 to 110.0
|
SECONDARY outcome
Timeframe: were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgeryeffect of intervention on the change of heart rate allover study period
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Heart Rate Change
after induction
|
74.9 beats/ minute
Standard Deviation 11.8
|
67.8 beats/ minute
Standard Deviation 6.8
|
85.9 beats/ minute
Standard Deviation 16.7
|
|
Heart Rate Change
1 minute after intubation
|
83.3 beats/ minute
Standard Deviation 11.1
|
73.3 beats/ minute
Standard Deviation 9.4
|
96.2 beats/ minute
Standard Deviation 18.8
|
|
Heart Rate Change
15 minutes after intubation
|
74.7 beats/ minute
Standard Deviation 8.8
|
66.6 beats/ minute
Standard Deviation 5.8
|
90.2 beats/ minute
Standard Deviation 19.8
|
|
Heart Rate Change
preinduction
|
82.6 beats/ minute
Standard Deviation 10.4
|
73.1 beats/ minute
Standard Deviation 9.5
|
85.8 beats/ minute
Standard Deviation 16
|
|
Heart Rate Change
5 minutes after intubation
|
77.1 beats/ minute
Standard Deviation 10
|
70.6 beats/ minute
Standard Deviation 8.8
|
89.3 beats/ minute
Standard Deviation 17.5
|
|
Heart Rate Change
10 minutes after intubation
|
75.4 beats/ minute
Standard Deviation 8.6
|
66.3 beats/ minute
Standard Deviation 5.4
|
87.8 beats/ minute
Standard Deviation 19.1
|
|
Heart Rate Change
30 minutes after intubation
|
73.4 beats/ minute
Standard Deviation 9.4
|
67.7 beats/ minute
Standard Deviation 4.9
|
85.8 beats/ minute
Standard Deviation 14.3
|
|
Heart Rate Change
45 minutes after intubation
|
75 beats/ minute
Standard Deviation 7.4
|
67.1 beats/ minute
Standard Deviation 4.2
|
80.1 beats/ minute
Standard Deviation 14.7
|
|
Heart Rate Change
60 minutes after intubation
|
75.3 beats/ minute
Standard Deviation 7.4
|
66.3 beats/ minute
Standard Deviation 4.8
|
87.3 beats/ minute
Standard Deviation 13.5
|
|
Heart Rate Change
75 minutes after intubation
|
75.7 beats/ minute
Standard Deviation 8.9
|
66 beats/ minute
Standard Deviation 4.3
|
84.5 beats/ minute
Standard Deviation 14.1
|
|
Heart Rate Change
90 minutes after intubation
|
72.7 beats/ minute
Standard Deviation 8.4
|
66.5 beats/ minute
Standard Deviation 3.4
|
88.1 beats/ minute
Standard Deviation 14.3
|
|
Heart Rate Change
105 minutes after intubation
|
75.7 beats/ minute
Standard Deviation 8.1
|
67.4 beats/ minute
Standard Deviation 5.7
|
97 beats/ minute
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgeryeffect of intervention on the change of mean arterial blood pressure allover study period
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Mean Arterial Blood Pressure Change
preinduction
|
85.6 mm Hg
Standard Deviation 6
|
86.4 mm Hg
Standard Deviation 6.6
|
92.4 mm Hg
Standard Deviation 9.8
|
|
Mean Arterial Blood Pressure Change
after induction
|
74.4 mm Hg
Standard Deviation 6.9
|
72.3 mm Hg
Standard Deviation 9.9
|
78.2 mm Hg
Standard Deviation 9.1
|
|
Mean Arterial Blood Pressure Change
1 minute after intubation
|
80.6 mm Hg
Standard Deviation 7.6
|
76.2 mm Hg
Standard Deviation 12.9
|
92.2 mm Hg
Standard Deviation 16.1
|
|
Mean Arterial Blood Pressure Change
5 minutes after intubation
|
70.7 mm Hg
Standard Deviation 8.4
|
67.2 mm Hg
Standard Deviation 7.8
|
78.6 mm Hg
Standard Deviation 11.1
|
|
Mean Arterial Blood Pressure Change
10 minutes after intubation
|
66.4 mm Hg
Standard Deviation 7.1
|
67.7 mm Hg
Standard Deviation 10.4
|
76.5 mm Hg
Standard Deviation 12.9
|
|
Mean Arterial Blood Pressure Change
15 minutes after intubation
|
65.4 mm Hg
Standard Deviation 4.6
|
70.2 mm Hg
Standard Deviation 8.8
|
74 mm Hg
Standard Deviation 12.1
|
|
Mean Arterial Blood Pressure Change
30 minutes after intubation
|
64.4 mm Hg
Standard Deviation 4.4
|
66.2 mm Hg
Standard Deviation 6.8
|
66.6 mm Hg
Standard Deviation 21.7
|
|
Mean Arterial Blood Pressure Change
60 minutes after intubation
|
61.9 mm Hg
Standard Deviation 4.2
|
66.7 mm Hg
Standard Deviation 4.8
|
69.9 mm Hg
Standard Deviation 11.3
|
|
Mean Arterial Blood Pressure Change
75 minutes after intubation
|
62.5 mm Hg
Standard Deviation 4.4
|
69.4 mm Hg
Standard Deviation 8.4
|
67.7 mm Hg
Standard Deviation 5.5
|
|
Mean Arterial Blood Pressure Change
45 minutes after intubation
|
63.3 mm Hg
Standard Deviation 3.4
|
64.7 mm Hg
Standard Deviation 6.6
|
64.6 mm Hg
Standard Deviation 14.3
|
|
Mean Arterial Blood Pressure Change
90 minutes after intubation
|
63 mm Hg
Standard Deviation 3.5
|
66.1 mm Hg
Standard Deviation 4.7
|
62.7 mm Hg
Standard Deviation 12.8
|
|
Mean Arterial Blood Pressure Change
105 minutes after intubation
|
63.1 mm Hg
Standard Deviation 3
|
67.2 mm Hg
Standard Deviation 7.7
|
70 mm Hg
Standard Deviation 14.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of surgerysurgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Surgeon Satisfaction (Categorical)
surgeon satisfaction not achieved(score< 4)
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Surgeon Satisfaction (Categorical)
surgeon satisfaction achieved (score≥ 4)
|
21 Participants
|
22 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of surgeryneed for additional intraoperative IV vasodilators (nitroglycerine
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure
|
0 Participants
|
0 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of surgerythe need for additional beta blockers (propranolol)
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at the end of surgeryneed for both IV nitroglycerine and propranolol intraoperatively
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure
|
0 Participants
|
0 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 3 and 6 hrs. after recoverypostoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0n full recovery, 3 and 6 hrs. after recoverypostoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) for Postoperative Pain
on full recovery
|
2 score on a scale
Interval 0.0 to 4.0
|
4 score on a scale
Interval 3.0 to 5.0
|
5 score on a scale
Interval 4.0 to 6.0
|
|
Visual Analogue Scale (VAS) for Postoperative Pain
3hrs. after recovery
|
1 score on a scale
Interval 0.0 to 3.0
|
3 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Visual Analogue Scale (VAS) for Postoperative Pain
6hrs after recovery
|
1 score on a scale
Interval 0.0 to 3.0
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: on administration of 1st postoperative rescue analgesiatime to 1st postoperative rescue analgesia (starting from administration of the studied drug)
Outcome measures
| Measure |
Gabapentin
n=21 Participants
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 Participants
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 Participants
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Time to 1st Postoperative Rescue Analgesia
|
60 minutes
Interval 0.0 to 90.0
|
30 minutes
Interval 20.0 to 50.0
|
20 minutes
Interval 0.0 to 30.0
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bisoprolol
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 11 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gabapentin
n=21 participants at risk
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 participants at risk
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 participants at risk
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Cardiac disorders
hypotension
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
4.5%
1/22 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
41.2%
7/17 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
|
Cardiac disorders
bradycardia
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
18.2%
4/22 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
23.5%
4/17 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
Other adverse events
| Measure |
Gabapentin
n=21 participants at risk
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
Bisoprolol
n=22 participants at risk
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
Control
n=17 participants at risk
placebo was given to patients of control group 2 hours preoperative
|
|---|---|---|---|
|
Cardiac disorders
hypertension
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
0.00%
0/22 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
58.8%
10/17 • Number of events 20 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
|
Cardiac disorders
tachycardia
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
0.00%
0/22 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
52.9%
9/17 • Number of events 18 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
|
Gastrointestinal disorders
postoperative nausea
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
13.6%
3/22 • Number of events 6 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
29.4%
5/17 • Number of events 10 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
|
Gastrointestinal disorders
postoperative vomiting
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
0.00%
0/22 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
5.9%
1/17 • Number of events 1 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
|
Nervous system disorders
agitation on recovery
|
0.00%
0/21 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
0.00%
0/22 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
29.4%
5/17 • Number of events 5 • intra-operative and up to 6 hours postoperative
hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
|
Additional Information
assistant professor Abeer M. Elnakera
faculty of medicine- Zagazig university
Phone: 00201005720754
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place