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

Anesthesia Clinical Trial

Official title:

The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06018948
• Other study ID #: 33360/09/19
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.

The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with Forced expiratory volume1/forced vital capacity<7.

• Uncontrolled cardiac, respiratory, hepatic or renal diseases.

• Allergy to the study drug

Related Conditions & MeSH terms

• Anesthesia
• Dexmedetomidine
• Obesity, Morbid

Intervention

Drug:
• Dexmedetomidine 0.6
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 0.3
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.
• Saline
Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dynamic Lung compliance	Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).	Intraoperative
Secondary	Post-operative pain	Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme	24 hour postoperatively
Secondary	Dead space (dead space to tidal volume)	Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %	Intraoperative
Secondary	Quality of recovery score	The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery	24 hours Postoperatively
Secondary	Time to first rescue analgesia	Time to first rescue analgesia as morphine consumption was recorded	24 hours Postoperatively
Secondary	Static lung compliance	Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).	Intraoperative
Secondary	Lung compliance	compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.	24 hours
Secondary	Plateau pressure	Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.	Intraoperative