Role of Intraoperative Beta Blocker for Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery

Phase 4

• Conditions: Postoperative Pain; Intraoperative Awareness
• Interventions: Drug: Esmolol

• Registration Number: NCT04086940
• Lead Sponsor: Ain Shams University

Brief Summary

Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.

Detailed Description

Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.

Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-12
• Status Verified: 2019-11
• Study Start: 2019-11
• Primary Completion: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anesthesiologists (ASA) I - II patients
• age between 18-59 years
• both genders
• body mass index (BMI) > 45 kg/m2

Exclusion Criteria

• Patients with -hepatic
• renal
• cardiac
• respiratory diseases
• patients with a history of drug abuse or who were dependent on opioid drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esmolol(breviblock) group	Esmolol	Patients in group E received a loading dose of esmolol(breviblock) 1 mg/kg in 50 ml isotonic saline over 30 minutes before induction of anesthesia, then followed by an infusion of esmolol 10 µg/kg/min until the end of the surgery.
non esmolol group	Esmolol	Patients in group N received 50 ml of isotonic saline over 30 min, followed by an infusion of isotonic saline at same rate of group E till the end of the surgery.

Primary Outcome Measures

Name	Time	Method
intraoperative analgesic requirements	6 months	amount of narcotics and anesthetics needed
postoperative analgesic requirements	6 months	amount of narcotics needed

Trial Locations

Locations (1)

Ramymahrose; 🇪🇬 Cairo, Egypt