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DEXDES Trial: Dexmedetomidine-Desflurane Combination in Laparoscopic Colectomy

NCT ID: NCT07239479

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-01-30

Brief Summary

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This randomized double-blind controlled clinical trial aims to evaluate the efficacy and safety of combining Dexmedetomidine with Desflurane in patients undergoing elective laparoscopic colectomy. The study will assess whether the combination can reduce Desflurane consumption, improve intraoperative hemodynamic stability, and enhance postoperative recovery compared to Desflurane alone.

Detailed Description

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Dexmedetomidine, a selective alpha-2 adrenergic agonist, has sedative and analgesic properties without significant respiratory depression. Desflurane, a volatile anesthetic with low blood-gas solubility, allows rapid induction and emergence. Combining these two agents may provide anesthetic-sparing effects and promote faster postoperative recovery under ERAS protocols. This study will enroll 40 adult patients undergoing elective laparoscopic colectomy at Tam Anh General Hospital, Vietnam. Participants will be randomized into two groups: Dexmedetomidine + Desflurane versus Desflurane alone. The primary outcome is average Desflurane consumption per hour, with secondary outcomes including hemodynamic parameters, Fentanyl use, emergence quality, and incidence of postoperative nausea and vomiting.

Conditions

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Colorectal Neoplasms

Keywords

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Dexmedetomidine Desflurane General anesthesia Colorectal surgery ERAS Hemodynamic stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine + Desflurane

Intervention Type DRUG

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.

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

Group Type PLACEBO_COMPARATOR

Desflurane + Normal Saline

Intervention Type DRUG

Normal saline infusion with identical timing and volume as the intervention group.

Desflurane administered at 1 MAC with EtControl mode.

Interventions

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Dexmedetomidine + Desflurane

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.

Intervention Type DRUG

Desflurane + Normal Saline

Normal saline infusion with identical timing and volume as the intervention group.

Desflurane administered at 1 MAC with EtControl mode.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tam Anh TP. Ho Chi Minh General Hospital

OTHER

Sponsor Role collaborator

Tam Anh Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tam Anh TP. Ho Chi Minh General Hospital

Ho Chi Minh City, Ho Chi Minh, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Phan Quoc Thai, MD

Role: CONTACT

Phone: +84 964 152 360

Email: [email protected]

Facility Contacts

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Phan Quoc Thai, MD

Role: primary

Other Identifiers

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TA2.25.11

Identifier Type: -

Identifier Source: org_study_id