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

NCT04086940 | Unknown Phase 4 DMC

• 1 other identifier: Ain Shams university 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraoperative Awareness; Postoperative Pain

Keywords

role; INTRAOPERATIVE; beta blocker; bariatric surgery; morbid obese

Outcome Measures

Primary Outcomes (2)

• intraoperative analgesic requirements

  amount of narcotics and anesthetics needed

  6 months

• postoperative analgesic requirements

  amount of narcotics needed

  6 months

Study Arms (2)

esmolol(breviblock) group

ACTIVE COMPARATOR

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

non esmolol group

ACTIVE COMPARATOR

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

Interventions

Esmolol DRUG

preventive

Also known as: normal saline

esmolol(breviblock) group; non esmolol group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ramymahrose

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Intraoperative Awareness; Pain, Postoperative

Interventions

esmolol; Saline Solution

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia at faculty of medicine ain shams university

Model Details: prospective randomized controlled study

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 12, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)