This trial is active, not recruiting.

Condition restrictive lung disease
Treatments dexmedetomidine, normal saline
Phase phase 4
Sponsor Cairo University
Start date September 2016
End date July 2017
Trial size 50 participants
Trial identifier NCT02843698, N-12-2016


The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Patients will receive either, Dexmedetomidine (Precedex, Hospira, Lake forest, IL, USA) in a dose of (1ug/Kg LBW) bolus followed by 0.5ug/Kg continuous infusion for one hour
Dexmedetomidine infusion was previously reported to improve oxygenation and lung dynamics in patients with obstructive lung diseases. In our study we are going to investigate its effect on oxygenation and lung dynamics in restrictive lung disease
(Placebo Comparator)
Patients will receive normal saline
normal saline
Normal saline

Primary Outcomes

time frame: after induction of anesthesia and every 30 minutes till the end of the operation

Secondary Outcomes

Lung mechanics
time frame: after induction of anesthesia and then every 30 minutes till the end of the operation

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Morbid obese (body mass index > 40) with documented restrictive lung disease scheduled to bariatric operation. Exclusion Criteria: - Heart failure - ِِِِArrhythmia - Heart block - Severe liver or kidney impairment.

Additional Information

Official title Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial
Description The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Cairo University.