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

Primary Purpose

Intraoperative Awareness, Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Esmolol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Awareness focused on measuring role, INTRAOPERATIVE, beta blocker, bariatric surgery, morbid obese

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ramymahrose

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

esmolol(breviblock) group

non esmolol group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

intraoperative analgesic requirements
amount of narcotics and anesthetics needed
postoperative analgesic requirements
amount of narcotics needed

Secondary Outcome Measures

Full Information

First Posted
September 5, 2019
Last Updated
November 21, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04086940
Brief Title
Role of Intraoperative Beta Blocker for Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery
Official Title
Lecturer of Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Awareness, Postoperative Pain
Keywords
role, INTRAOPERATIVE, beta blocker, bariatric surgery, morbid obese

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
esmolol(breviblock) group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
non esmolol group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Esmolol
Other Intervention Name(s)
normal saline
Intervention Description
preventive
Primary Outcome Measure Information:
Title
intraoperative analgesic requirements
Description
amount of narcotics and anesthetics needed
Time Frame
6 months
Title
postoperative analgesic requirements
Description
amount of narcotics needed
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ramymahrose
City
Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
after publication

Learn more about this trial

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

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