Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery

NCT03850093 | Completed Phase 4 Results

• 1 other identifier: ZU-IRB 2139-24-5-2015
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Blood Pressure

Keywords

gabapentin; bisoprolol; hemodynamic; surgical field

Outcome Measures

Primary Outcomes (2)

• Changes in Surgical Field Visibility

  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.

  scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end

• Blood Loss

  total intraoperative blood loss (mL)

  at the end of surgery

Secondary Outcomes (2)

• Heart Rate Change

  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

  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 Outcomes (7)

• Surgeon Satisfaction (Categorical)

  at the end of surgery

• Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure

  at the end of surgery

• Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure

  at the end of surgery

Study Arms (3)

gabapentin

ACTIVE COMPARATOR

gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative

Drug: Gabapentin1200 mg

bisoprolol

ACTIVE COMPARATOR

bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative

Drug: bisoprolol 2.5mg

control

PLACEBO COMPARATOR

placebo was given to patients of control group 2 hours preoperative

Drug: placebo

Interventions

Gabapentin1200 mg DRUG

patients received 1200mg gabapentin 2 hrs preoperative

Also known as: gaptin

gabapentin

bisoprolol 2.5mg DRUG

patients received 2.5mg bisoprolol 2 hrs preoperative

Also known as: concor

bisoprolol

placebo DRUG

patients received oral placebo 2 hrs preoperative

Also known as: vitamins

control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who underwent functional endoscopic sinus surgery
• ability to swallow tablets

You may not qualify if:

• suspected difficult airway
• basal HR \<60/min.
• chronic cardiovascular or cerebrovascular disease
• bronchial asthma or COPD
• 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.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Interventions

Bisoprolol; Vitamins

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

small sample size, short study period (until 6 hrs. postoperatively) and unavailability of BIS index monitoring.

Results Point of Contact

• Title: assistant professor Abeer M. Elnakera
• Organization: faculty of medicine- Zagazig university

nakera35@hotmail.com

00201005720754

Study Officials

• Abeer M. Elnakera, doctorate

  faculty of medicine - Zagazig university

  PRINCIPAL INVESTIGATOR

• Ayman A. Hassan, doctorate

  Zagazig University

  STUDY CHAIR

• Maram wagdy, Master

  Zagazig University

  STUDY CHAIR

• Mohamed W. El-Anwar, doctorate

  Zagazig University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 7, 2020
• Results First Posted: August 12, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share