- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03850093
Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery
Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery
the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate .
A prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):-
- Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia.
- Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia.
- Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypothesis:
Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate.
Objectives Compare the effect of preoperative Gabapentin with Bisoprolol on hemodynamics, surgical field optimization during endoscopic nasal surgeries.
Technical design:
A) Site of study :
The study was conducted at Anesthesia and Surgical intensive care and Otorhinolaryngology departments, faculty of medicine, Zagazig University.
B) Sample Size :
According to 80% power of the study, 95% CI and calculated volume of blood loss 200±40 ml and 150±55ml on Gabapentin (22) and Bisoprolol (15) premedication respectively, the estimated Sample size was 54 patients (open EPI) , 63 patients were included in the study to compensate for drop out.
Randomization was carried out on 63 patients to compensate for drop out . All planned ESS procedures was managed by the same anesthetist and surgeon who were blinded to the used study's premedication. The surgeon was blinded to the monitor recording the hemodynamic variables.
All patients had been preoperatively evaluated according to standard local protocol. Preoperative surgical preparation and proper management of infection were confirmed to every patient.
Patient was premedicated by IV ranitidine 50 mg, midazolam 0.05 mg/kg and atropine 20µg/kg immediately before admission to the operating room.
On admission to the operating room, Standard monitoring included 5 leads ECG, non-invasive blood pressure, Pulse Oximetry and End-tidal carbon dioxide (ETCO2) trace were applied (B40i Monitor - GE Healthcare, Finland).
Anesthesia was induced with IV propofol 2 mg/kg and fentanyl 1 µg/kg was given for analgesia. Cisatracurium 0.15 mg/kg IV was given to facilitate direct laryngoscopy and orotracheal intubation. The patient was ventilated at tidal volume 6-8mL/kg and respiratory rate that achieved ETCO2 of 30-35 mmHg. Oropharyngeal pack was inserted.
Anesthesia was maintained by isoflurane based on MAC 1.2 % until a steady state of anesthesia was achieved (defined as a state of anesthesia when no changes in hemodynamic variables take place for at least 10 min). An increase of ≥ 20% of basal value in both HR and MAP was treated with increasing the concentration of isoflurane by 0.5% and increments of fentanyl 1 μg/kg. Muscle relaxation was confirmed by cisatracurium 0.03mg/kg every 20 mins. IV lactated ringer solution was infused at approximately 6ml/kg/hr till the end of the procedure.
All patients were positioned supine and the bed-head of the surgical table was raised by 30° to improve venous drainage.
Before the beginning of surgical procedure, well wrung out cotton pledgets soaked with 4 ml of 2% lignocaine with 1:200,000 adrenaline were topically applied to the nasal mucous membrane for 10 min (no infiltration).
Technique for hemodynamic optimization:
Target mean arterial pressure (MAP) was 60-70 mmHg during the surgical procedure to achieve Fromm and Boezaart category scale of 2 or 3 which is judged to be optimal for surgery (20).
If the MAP was still ˃70mmHg in spite of increasing isoflurane inhalation to 2.5%, nitroglycerine (1-10 μg/kg/min.) titrated to effect.
If the heart rate was more than 100 beats/ minute, propranolol was titrated 1-3 mg/hour to achieve target MAP.
If mean arterial pressure (MAP) decreased to less than 60 mm Hg, ephedrine in increments of 3 mg was given.
Withdrawal vasoactive agents:
After recording the surgeons' opinion regarding the surgical field and about 15 minutes before ending surgery, the infusion of any vasoactive medication (if used) was stopped and the anesthetic agent was decreased allowing HR and MAP to return to their basal value. If Hypotension (defined as SAP< 90mmHg and bradycardia less than 60 bpm) persisted, they was treated by ephedrine in increments of 3 mg .
On compilation of surgical procedure, anesthesia was discontinued and reversal of neuromuscular blockade was achieved using IV neostigmine 0.08 mg/kg and atropine 20µg/kg. After removal of oropharyngeal pack, oropharyngeal suction was performed. On the start of obeying commands, patients were extubated and shifted to recovery room.
Patients were discharged to the ward after reaching a score ≥ 9 on the Modified Aldrete Scoring System.
During postoperative period up to 6 hours, the patient was monitored for conscious level, oxygen saturation, heart rate and mean arterial blood pressure.
On ward admission, IM diclofenac sodium 75mg was given then every 12 hours. If the patient complained moderate to severe pain (VAS≥ 4) meperidine 25mg increments up to pain relief (maximum 100mg as a single dose) was given.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients who underwent functional endoscopic sinus surgery
- ability to swallow tablets
Exclusion Criteria:
- suspected difficult airway
- basal HR <60/min.
- chronic cardiovascular or cerebrovascular disease
- bronchial asthma or COPD
- DM
- bleeding disorders
- anemia (Hb level< 10 gm/dl)
- renal or hepatic insufficiency
- psychiatric disorders
- chronic treatment by BBs, gabapentin or drugs that affect coagulation
- acute nasal infection
- allergy/contraindications to any of the study's drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: gabapentin
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
|
patients received 1200mg gabapentin 2 hrs preoperative
Other Names:
|
Active Comparator: bisoprolol
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
|
patients received 2.5mg bisoprolol 2 hrs preoperative
Other Names:
|
Placebo Comparator: control
placebo was given to patients of control group 2 hours preoperative
|
patients received oral placebo 2 hrs preoperative
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Surgical Field Visibility
Time Frame: scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end
|
according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.
|
scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end
|
Blood Loss
Time Frame: at the end of surgery
|
total intraoperative blood loss (mL)
|
at the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Change
Time Frame: 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 surgery
|
effect of intervention on the change of heart rate allover study period
|
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 surgery
|
Mean Arterial Blood Pressure Change
Time Frame: 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 surgery
|
effect of intervention on the change of mean arterial blood pressure allover study period
|
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 surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgeon Satisfaction (Categorical)
Time Frame: at the end of surgery
|
surgeon 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
|
at the end of surgery
|
Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure
Time Frame: at the end of surgery
|
need for additional intraoperative IV vasodilators (nitroglycerine
|
at the end of surgery
|
Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure
Time Frame: at the end of surgery
|
the need for additional beta blockers (propranolol)
|
at the end of surgery
|
Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure
Time Frame: at the end of surgery
|
need for both IV nitroglycerine and propranolol intraoperatively
|
at the end of surgery
|
Visual Analogue Scale (VAS) for Postoperative Pain
Time Frame: 1, 3 and 6 hrs. after recovery
|
postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed
|
1, 3 and 6 hrs. after recovery
|
Visual Analogue Scale (VAS) for Postoperative Pain
Time Frame: 0n full recovery, 3 and 6 hrs. after recovery
|
postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain
|
0n full recovery, 3 and 6 hrs. after recovery
|
Time to 1st Postoperative Rescue Analgesia
Time Frame: on administration of 1st postoperative rescue analgesia
|
time to 1st postoperative rescue analgesia (starting from administration of the studied drug)
|
on administration of 1st postoperative rescue analgesia
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abeer M. Elnakera, doctorate, Faculty of Medicine - Zagazig University
- Study Chair: Ayman A. Hassan, doctorate, Zagazig University
- Study Chair: Maram wagdy, Master, Zagazig University
- Study Chair: Mohamed W. El-Anwar, doctorate, Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Gabapentin
- Bisoprolol
Other Study ID Numbers
- ZU-IRB 2139-24-5-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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