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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06018948
Other study ID # 33360/09/19
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2019
Est. completion date September 30, 2021

Study information

Verified date August 2023
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 90
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine 0.6
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
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
Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Intraoperative
Secondary Dynamic Lung compliance Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure). Intraoperative
Secondary 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 24 hour postoperatively
Secondary 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 % Intraoperative
Secondary 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 24 hours Postoperatively
Secondary Time to first rescue analgesia Time to first rescue analgesia as morphine consumption was recorded 24 hours Postoperatively
Secondary Static lung compliance Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure). Intraoperative
Secondary Lung compliance compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance. 24 hours
Secondary Plateau pressure Plateau pressure was calculated by increasing end inspiratory pause to 30-40%. Intraoperative
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