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

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04086940
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Days)
60.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomized controlled studyprospective randomized controlled study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Lecturer of Anesthesia
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intraoperative analgesic requirements [6 months]

      amount of narcotics and anesthetics needed

    2. postoperative analgesic requirements [6 months]

      amount of narcotics needed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ramymahrose Cairo Egypt 02

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RAMY AHMED, lecturer of anesthesia at faculty of medicine ain shams university, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04086940
    Other Study ID Numbers:
    • Ain Shams university 1
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Nov 25, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by RAMY AHMED, lecturer of anesthesia at faculty of medicine ain shams university, Ain Shams University
    role
    INTRAOPERATIVE
    beta blocker
    bariatric surgery
    morbid obese
    Additional relevant MeSH terms:
    Intraoperative Awareness
    Esmolol

    Study Results

    No Results Posted as of Nov 25, 2019