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

NCT ID: NCT04086940

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2019-12-31

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.

Conditions

Intraoperative Awareness; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

esmolol(breviblock) group

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.

Group Type: ACTIVE_COMPARATOR

Esmolol

Intervention Type: DRUG

preventive

non esmolol group

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.

Group Type: ACTIVE_COMPARATOR

Esmolol

Intervention Type: DRUG

preventive

Interventions

Esmolol

preventive

Intervention Type: DRUG

Other Intervention Names

normal saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

RAMY AHMED

lecturer of anesthesia at faculty of medicine ain shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ramymahrose

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Ain Shams university 1

Identifier Type: -

Identifier Source: org_study_id