The Effect of Dexmedetomidine on Postoperative Quality of Recovery

NCT ID: NCT03468062

Last Updated: 2019-02-15

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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The Effect of Dexmedetomidine on Postoperative Quality of Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dexmedetomidine

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungmi Kim

OTHER

Sponsor Role lead

Responsible Party

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Kyungmi Kim

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gil Medical Center, Gachon University College of Medicine

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33546069 (View on PubMed)

Other Identifiers

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GAIRB2018-071

Identifier Type: -

Identifier Source: org_study_id

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