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NCT Number: NCT06018948

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 0.3

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.

Saline

Drug

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

Primary outcomes

  1. Intraoperative oxygenation

    Time frame: Intraoperative

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

Secondary outcomes

  1. Dynamic Lung compliance

    Time frame: Intraoperative

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

  2. Post-operative pain

    Time frame: 24 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

  3. Dead space (dead space to tidal volume)

    Time frame: 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 %

  4. Quality of recovery score

    Time frame: 24 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

  5. Time to first rescue analgesia

    Time frame: 24 hours Postoperatively

    Time to first rescue analgesia as morphine consumption was recorded

  6. Static lung compliance

    Time frame: Intraoperative

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

  7. Lung compliance

    Time frame: 24 hours

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

  8. Plateau pressure

    Time frame: Intraoperative

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2023
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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