Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients

NCT06018948 | Completed Phase 4 DMC

• 1 other identifier: 33360/09/19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.

Conditions

Anesthesia; Obesity, Morbid; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Intraoperative oxygenation

  Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.

  Intraoperative

Secondary Outcomes (8)

• Dynamic Lung compliance

  Intraoperative

• Post-operative pain

  24 hour postoperatively

• Dead space (dead space to tidal volume)

  Intraoperative

• Quality of recovery score

  24 hours Postoperatively

• Time to first rescue analgesia

  24 hours Postoperatively

Study Arms (3)

Dexmedetomidine 0.6 group

ACTIVE COMPARATOR

patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.

Drug: Dexmedetomidine 0.6

Dexmedetomidine 0.3group

ACTIVE COMPARATOR

patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.

Drug: Dexmedetomidine 0.3

Control group

PLACEBO COMPARATOR

Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.

Drug: Saline

Interventions

Dexmedetomidine 0.6 DRUG

Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.

Dexmedetomidine 0.6 group

Dexmedetomidine 0.3 DRUG

Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.

Dexmedetomidine 0.3group

Saline DRUG

Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) \<70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
• Aged 18-50 years.
• Scheduled for abdominal surgery.

You may not qualify if:

• Patients with Forced expiratory volume1/forced vital capacity\<7.
• Uncontrolled cardiac, respiratory, hepatic or renal diseases.
• Allergy to the study drug

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in Anesthesiology, Surgical ICU and Pain Medicine

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 31, 2023

Record last verified: 2023-08

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)