The Effect of Dexmedetomidine on Postoperative Quality of Recovery

The Effect of Dexmedetomidine on Postoperative Quality of Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03468062
• Other study ID #: GAIRB2018-071
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 9, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2019
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• The Effect of Dexmedetomidine on Postoperative Quality of Recovery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gil Medical Center, Gachon University College of Medicine	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Kyungmi Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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