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Dexmedetomidine + Ketamine for Postoperative Pain

N/A
Recruiting
Led By Veronique Brulotte, MD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society of Anesthesiology physical status I-III
Patients aged 18-80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will help determine if using a combination of ketamine and dexmedetomidine can help reduce postoperative pain after VATS surgery.

Who is the study for?
This trial is for adults aged 18-80 undergoing elective lung surgery (VATS) who are generally healthy or have mild to moderate systemic disease. It's not for those planning to use regional anesthesia post-surgery, on certain pain medications like beta-blockers or chronic pain treatments, with allergies to the study drugs, pregnant, unable to consent, or facing language barriers.Check my eligibility
What is being tested?
The study tests if combining two non-opioid drugs—dexmedetomidine and ketamine—during surgery can better reduce the need for morphine afterward compared to using each drug alone. The goal is a further 30% reduction in morphine use after VATS when both drugs are infused together.See study design
What are the potential side effects?
Dexmedetomidine may cause low blood pressure, slow heart rate, and dry mouth. Ketamine might lead to changes in blood pressure and heart rate, dizziness, nausea, hallucinations or unusual dreams during recovery from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health is good to moderately impaired according to anesthesia standards.
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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Day 1 Postoperative morphine requirement
Secondary outcome measures
Pain score at cough 24h
Pain score at cough 48h
Pain score at rest 24h
+5 more

Trial Design

3Treatment groups
Active Control
Group I: Ketamine hydrochlorideActive Control1 Intervention
Intraoperative bolus (0.25 mg/kg) and infusion (0.25mg/kg/h) of ketamine plus an intraoperative bolus (over 20 min) and infusion of normal saline;
Group II: dexmedetomidine hydrochlorideActive Control1 Intervention
Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5µg/kg/h) of dexmedetomidine plus an intraoperative bolus and infusion of normal saline
Group III: dexmedetomidine hydrochloride and ketamine hydrochlorideActive Control1 Intervention
Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5 µg/g/h) of dexmedetomidine plus an intraoperative bolus (0.25mg/kg) and infusion (0.25mg/kg/h) of ketamine

Find a Location

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,440 Total Patients Enrolled
2 Trials studying Postoperative Pain
2 Patients Enrolled for Postoperative Pain
Veronique Brulotte, MDPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal
3 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Postoperative Pain
2 Patients Enrolled for Postoperative Pain

Media Library

Ketamine hydrochloride Clinical Trial Eligibility Overview. Trial Name: NCT03596424 — N/A
Postoperative Pain Research Study Groups: Ketamine hydrochloride, dexmedetomidine hydrochloride, dexmedetomidine hydrochloride and ketamine hydrochloride
Postoperative Pain Clinical Trial 2023: Ketamine hydrochloride Highlights & Side Effects. Trial Name: NCT03596424 — N/A
Ketamine hydrochloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596424 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any qualifications to participant in this research trial?

"To qualify for this medical trial, candidates must be in postoperative pain and between 18 to 80 years of age. Currently, the study is targeting a cohort of 120 individuals."

Answered by AI

Does the upper age limit for participation in this research exceed 30 years?

"This clinical trial is seeking individuals between 18 and 80 years of age. However, there are alternative options for those younger than 18 (127 trials) or older than 65 (610 trials)."

Answered by AI

What is the estimated size of the cohort in this experiment?

"Affirmative. According to records on clinicaltrials.gov, this investigation is presently recruiting patients who meet their criteria. The trial was first publicized on February 1st 2018 and has been updated as recent as May 19th 2022. At the moment, 120 participants are required for the study at a single site."

Answered by AI

Are there still opportunities to participate in this experimental procedure?

"Per the information available via clinicaltrials.gov, this research endeavor is currently recruiting participants. The trial was initially made public on February 1st 2018 and its most recent revision dates back to May 19th 2022."

Answered by AI

What other research has been conducted regarding Ketamine hydrochloride?

"At the current moment, 201 trials related to the use of ketamine hydrochloride are underway. 38 of these clinical studies have progressed into Phase 3 and they are primarily situated in Pittsburgh, Pennsylvania with 348 other sites participating as well."

Answered by AI

In what therapeutic scenarios is Ketamine hydrochloride generally used?

"Ketamine hydrochloride is the preferred choice for general anesthesia, as well as its use in other treatments such as various medical procedures, diseases and mechanical ventilations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dexmedetomidine and Ketamine in VATS Surgery
Veronique Brulotte 2018. "Dexmedetomidine and Ketamine in VATS Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03596424.
~10 spots leftby Dec 2024
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