- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239479
DEXDES Trial: Dexmedetomidine-Desflurane Combination in Laparoscopic Colectomy
Efficacy and Safety of Dexmedetomidine Combined With Desflurane in Laparoscopic Colectomy: A Randomized Double-Blind Controlled Clinical Trial (DEXDES Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Phan Quoc Thai, MD
- Phone Number: +84 964 152 360
- Email: thaipq@tahospital.vn
Study Locations
-
-
Ho Chi Minh
-
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
- Recruiting
- Tam Anh TP. Ho Chi Minh General Hospital
-
Contact:
- Phan Quoc Thai, MD
- Email: thaipq@tahospital.vn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years
- ASA Physical Status I-II
- Elective laparoscopic colectomy
- Written informed consent provided
Exclusion Criteria:
- Severe cardiac, hepatic, or renal disease
- COPD or bronchial asthma
- Chronic opioid or psychotropic medication use
- Atrioventricular block (grade II-III), sick sinus syndrome
- Significant intraoperative bleeding or hemodynamic instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Arm 1 - Dexmedetomidine + Desflurane (Intervention Group): Dexmedetomidine bolus 1 µg/kg IV over 15 minutes before induction, followed by continuous infusion 0.5 µg/kg/h during surgery. Desflurane administered at 1 MAC with EtControl mode. |
Dexmedetomidine bolus 1 µg/kg IV over 15 minutes before induction, followed by continuous infusion 0.5 µg/kg/h during surgery. Desflurane administered at 1 MAC with EtControl mode. |
|
Placebo Comparator: Control Group
Arm 2 - Desflurane + Normal Saline (Control Group): Normal saline infusion with identical timing and volume as the intervention group. Desflurane administered at 1 MAC with EtControl mode |
Normal saline infusion with identical timing and volume as the intervention group. Desflurane administered at 1 MAC with EtControl mode. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Desflurane consumption per hour (mL/h) during surgery.
Time Frame: During surgery
|
Average Desflurane consumption per hour (mL/h) during surgery.
|
During surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Colorectal Neoplasms
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Pharmaceutical Preparations
- Ethers
- Azoles
- Hydrocarbons
- Imidazoles
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Hydrocarbons, Halogenated
- Hydrocarbons, Fluorinated
- Methyl Ethers
- Ethyl Ethers
- Desflurane
- Dexmedetomidine
- Saline Solution
Other Study ID Numbers
- TA2.25.11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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