NCT03468062

Brief Summary

Dexmedetomidine is a selective a2-agonist and a sedative with anti-inflammatory,analgesic, and antiemetic effects, and its use for procedural sedation during endoscopy or ablation for atrial fibrillation has been increasing. It is also used for sedation in the intensive care unit. Recently, it was reported that dexmedetomidine is often used as an adjuvant for general anesthesia. Sympatholysis of dexmedetomidine can attenuate the increased sympathetic tone after surgery and result in antistress effects. In addition, opioid-sparing and analgesic effects are promoted by the perioperative administration of dexmedetomidine. Although it has been reported that the perioperative administration of dexmedetomidine improves quality of recovery after spinal and ENT surgeries, the outcomes for patients who undergo laparoscopic cholecystectomy remain poorly investigated. The aims of this study were to evaluate the effects of preoperative dexmedetomidine administration on quality of recovery by using the QoR-40 questionnaire in patients who undergo laparoscopic cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 9, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

March 11, 2018

Last Update Submit

February 12, 2019

Conditions

The Effect of Dexmedetomidine on Postoperative Quality of Recovery

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery questionnaire

    The Quality of Recovery questionnaire (QoR-40) is a tool used to assess the quality of recovery after surgery through questions pertaining to 40 items related to 5 domains. It has been validated as a global and reliable measurement tool.

    postoperative first day

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

0.5 mg/kg of dexmedetomidine (Precedex; Hospira, Lake Forest, IL) is mixed in normal saline 100mL and administered for 5 minutes after anesthetic induction.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Only normal saline 100mL is administered for 5 minutes after anesthetic induction.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.

Also known as: Placebo
DexmedetomidinePlacebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who undergo elective cholecystectomy
  • Adults (20\~75 years old)
  • an American Society of Anesthesiologists physical status of I or II

You may not qualify if:

  • The patients do not provide written informed consent
  • The patients have had allergic response to dexmedetomidine.
  • The patients have mood disorder or anxiety disorder.
  • The patients are not able to express their emotions.
  • The pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gil Medical Center, Gachon University College of Medicine

Incheon, 21556, South Korea

Location

Related Publications (1)

  • Choi JJ, Kim K, Park HY, Chang YJ, Lee KC, Kim KY, Kwak HJ. CONSORT the effect of a bolus dose of dexmedetomidine on postoperative pain, agitation, and quality of recovery after laparoscopic cholecystectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24353. doi: 10.1097/MD.0000000000024353.

    PMID: 33546069DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 16, 2018

Study Start

May 9, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)