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

Tanta University90 enrolled

Overview

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.

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia Obesity, Morbid Dexmedetomidine

Interventions

Dexmedetomidine 0.6DRUG

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 0.3DRUG

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.

SalineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative

Secondary Outcomes

Dynamic Lung compliance

Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).

Time frame: Intraoperative

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

Time frame: 24 hour postoperatively

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 %

Time frame: Intraoperative

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

Time frame: 24 hours Postoperatively

Time to first rescue analgesia

Time to first rescue analgesia as morphine consumption was recorded

Time frame: 24 hours Postoperatively

Static lung compliance

Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).

Data from ClinicalTrials.gov

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