- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03468062
The Effect of Dexmedetomidine on Postoperative Quality of Recovery
The Effect of Preoperative Intravenous Dexmedetomidine on Postoperative Quality of Recovery: Randomized Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Incheon, Korea, Republic of, 21556
- Gil Medical Center, Gachon University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.
Other Names:
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Placebo Comparator: Placebo
Only normal saline 100mL is administered for 5 minutes after anesthetic induction.
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Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of recovery questionnaire
Time Frame: postoperative first day
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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.
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postoperative first day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- GAIRB2018-071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Tianjin Medical University General HospitalShehzaad Joomye; Haiyun Wang; Donglai YanUnknownThe Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index. | Effect of Dexmedetomidine on Sufentanil Consumption. | Quantitative Analysis of Cisatracurium Infusion Requirements, Sufentanil Consumption and Recovery Index in Different Age...China
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