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Clinical Trials/NCT03468062
NCT03468062
Unknown
Phase 4

The Effect of Preoperative Intravenous Dexmedetomidine on Postoperative Quality of Recovery: Randomized Study

Kyungmi Kim1 site in 1 country90 target enrollmentMay 9, 2018

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
The Effect of Dexmedetomidine on Postoperative Quality of Recovery
Sponsor
Kyungmi Kim
Enrollment
90
Locations
1
Primary Endpoint
Quality of recovery questionnaire
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2018
End Date
August 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Kyungmi Kim

Assistant Professor

Gachon University Gil Medical Center

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Dexmedetomidine

Placebo

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

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Quality of recovery questionnaire

Time Frame: postoperative first day

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.

Study Sites (1)

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