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

Phase 4
Completed
Conditions
Anesthesia
Dexmedetomidine
Obesity, Morbid
Interventions
Registration Number
NCT06018948
Lead Sponsor
Tanta University
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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dexmedetomidine 0.6 groupDexmedetomidine 0.6patients 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.
Control groupSalinePatients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.
Dexmedetomidine 0.3groupDexmedetomidine 0.3patients 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.
Primary Outcome Measures
NameTimeMethod
Intraoperative oxygenationIntraoperative

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

Secondary Outcome Measures
NameTimeMethod
Dynamic Lung complianceIntraoperative

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

Quality of recovery score24 hours Postoperatively

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 to first rescue analgesia24 hours Postoperatively

Time to first rescue analgesia as morphine consumption was recorded

Plateau pressureIntraoperative

Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.

Lung compliance24 hours

compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.

Post-operative pain24 hour postoperatively

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

Dead space (dead space to tidal volume)Intraoperative

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 %

Static lung complianceIntraoperative

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

Trial Locations

Locations (1)

Tanta University

🇪🇬

Tanta, El-Gharbia, Egypt

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