The Effect of Dexmedetomidine on Postoperative Quality of RecoveryPhase 4NCT03468062
The Effect of Dexmedetomidine on Postoperative Quality of Recovery
A Phase 4 study testing Dexmedetomidine in people with The Effect of Dexmedetomidine on Postoperative Quality of Recovery, run by Kyungmi Kim at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- The Effect of Dexmedetomidine on Postoperative Quality of Recovery
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2018to 31 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who undergo elective cholecystectomy
- Adults (20~75 years old)
- an American Society of Anesthesiologists physical status of I or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gil Medical Center, Gachon University College of Medicine
Incheon, 21556
About this study
Official title: 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.
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Placebo
Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 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. Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Only normal saline 100mL is administered for 5 minutes after anesthetic induction. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start9 May 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Effect of Dexmedetomidine on Postoperative Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungmi Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyungmi Kim, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468062
- Sponsor's protocol ID
- GAIRB2018-071
- Status last verified
- Feb 2019
- First submitted
- 11 Mar 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33546069
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Intravenous Dexmedetomidine on Postoperative Quality of Recovery: Randomized Study
- ClinicalTrials.gov ID
- NCT03468062
- Acronym / sponsor ID
- GAIRB2018-071
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kyungmi KimUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine0.5 mg/kg of dexmedetomidine (Precedex; Hospira, Lake Forest, IL) is mixed in normal saline 100mL and administered for 5 minutes after anesthetic induction. |
| Placebo | Placebo comparator | Drug: DexmedetomidineOnly normal saline 100mL is administered for 5 minutes after anesthetic induction. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients who undergo elective cholecystectomy
- Adults (20~75 years old)
- an American Society of Anesthesiologists physical status of I or II
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PlaceboPatients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia. | Drug | Dexmedetomidine, Placebo |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 33546069Choi 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.
- Individual participant dataSharing planned: No
Related trials for The Effect of Dexmedetomidine on Postoperative Quality of Recovery
Not yet recruiting
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Enrolling by invitation
The Effect of Esketamine Combined With Dexmedetomidine on Postoperative Recovery Quality in Patients Undergoing Thoracoscopic Surgery
Esketamine Plus Dexmedetomidine Affect Postoperative Quality, Thoracoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with The Effect of Dexmedetomidine on Postoperative Quality of Recovery, run by Kyungmi Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery questionnaire (time frame: postoperative first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.