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

November 21, 2019 updated by: RAMY AHMED, Ain Shams University

Lecturer of Anesthesia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Ramymahrose

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Esmolol
preventive
Other Names:
  • normal saline
ACTIVE_COMPARATOR: 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.
Drug: Esmolol
preventive
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative analgesic requirements
Time Frame: 6 months
amount of narcotics and anesthetics needed
6 months
postoperative analgesic requirements
Time Frame: 6 months
amount of narcotics needed
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (ACTUAL)

September 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams university 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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