Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery

NCT07054138 | Completed

• 1 other identifier: KFSIRB200-20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation, pneumoperitoneum, and opioid consumption in morbidly obese patients undergoing laparoscopic bariatric surgery.

Conditions

Nebulization; Dexmedetomidine; Hemodynamic Changes; Intubation; Pneumoperitoneum; Morbid Obesity; Laparoscopic Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of increase in hemodynamic response

  Incidence of increase in hemodynamic response, either heart rate, mean arterial pressure, or both.

  Intraoperatively

Secondary Outcomes (6)

• Preoperative sedation score

  Preoperatively

• Intraoperative fentanyl consumption

  Intraoperatively

• Intraoperative propofol consumption

  Intraoperatively

• Time for first use of rescue analgesia

  24 hours postoperatively

• Total opioid consumption

  24 hours postoperatively

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Patients will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to the operating room with a face mask 6 L/min in a sitting position.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

Patients will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to the operating room with a face mask 6 L/min in a sitting position.

Dexmedetomidine group

Normal Saline DRUG

Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to the operating room with a face mask, 6 L/min in a sitting position.

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 to 60 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) Physical Status I-III.
• Morbidly obese patients with a body mass index (BMI) between 30 and 45.

You may not qualify if:

• Patients' refusal
• Decompansated hepatic, renal, or cardiac disease
• Expected difficult airway management
• Uncontrolled hypertension
• Psychiatric disease
• Sever pulmonary disease
• Patients on opioid, alcohol, beta-blockers, or allergy to any of the study drugs.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pneumoperitoneum; Obesity, Morbid

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 8, 2025
• Study Start: July 10, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)