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

T

Tanta University

Status and phase

Completed
Phase 4

Conditions

Dexmedetomidine
Obesity, Morbid
Anesthesia

Treatments

Drug: Dexmedetomidine 0.3
Drug: Saline
Drug: Dexmedetomidine 0.6

Study type

Interventional

Funder types

Other

Identifiers

NCT06018948
33360/09/19

Details and patient eligibility

About

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.

Full 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 .

Enrollment

90 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups, including a placebo group

Dexmedetomidine 0.6 group
Active Comparator group
Description:
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.
Treatment:
Drug: Dexmedetomidine 0.6
Dexmedetomidine 0.3group
Active Comparator group
Description:
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.
Treatment:
Drug: Dexmedetomidine 0.3
Control group
Placebo Comparator group
Description:
Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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