The Effect of Dexmedetomidine on Postoperative Quality of Recovery

Phase 4

• Conditions: The Effect of Dexmedetomidine on Postoperative Quality of Recovery
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03468062
• Lead Sponsor: Kyungmi Kim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Study Start: 2018-05-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Dexmedetomidine	Only normal saline 100mL is administered for 5 minutes after anesthetic induction.
Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Quality of recovery questionnaire	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.

Trial Locations

Locations (1)

Gil Medical Center, Gachon University College of Medicine; 🇰🇷 Incheon, Korea, Republic of