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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

Must not have

Patients with chronic pain taking >60 mg morphine PO daily (or its equivalent)

Inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 60 mg of morphine daily for chronic pain.

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I am unable to understand and agree to the study's details.

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I have chosen not to participate in this trial.

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I am taking beta-blockers before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Day 1 Postoperative morphine requirement

Secondary study objectives

Pain score at cough 24h

Pain score at cough 48h

Pain score at rest 24h

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met