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Dexmedetomidine and Ketamine in VATS Surgery

ConditionsPostoperative PainOpioid Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

Postoperative pain after VATS surgery is significant and associated with moderate to high post operative morphine requirements, which can cause opioid related side effects and delay postoperative recovery. To reduce this requirement, multimodal analgesia with non opioid medication such as dexmedetomidine and ketamine can be used. These drugs have demonstrated significant opioid-sparing properties after various types of surgeries. However, very little is known about their ability to do so in VATS surgery. Also, their relative opioid-sparing properties have not been compared, and it is not known whether their combined use can lead to an additional opioid-sparing effect. The primary goal of this study will be to determine the impact of a combined intra operative infusion of ketamine and dexmedetomidine on postoperative morphine requirements in patients undergoing elective VATS, compared to both these drugs infused separately.

The hypothesis is that this combined infusion will lead to a 30% further reduction in morphine requirements, 24h after surgery, compared to both these drugs infused separately.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-80 years old

American Society of Anesthesiology physical status I-III

Elective Video-Assisted Thoracic Surgery for pulmonary resection

Disqualifiers

Patients for which a regional anesthesia technique is planned for postoperative analgesia.

Patients taking beta-blockers preoperatively.

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

Patients taking pregabalin, gabapentin, amitryptillin, nortryptillin and/or duloxetin.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine Hydrochloride

    Drug

    Intraoperative bolus and infusion (see arm description)

  • Dexmedetomidine Hydrochloride

    Drug

    Intraoperative bolus and infusion (see arm description)

  • dexmedetomidine Hydrochloride and Ketamine Hydrochloride

    Combination product

    Intraoperative bolus and infusion (see arm description)

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Ketamine hydrochlorideActive comparator 1 intervention
Group B: dexmedetomidine hydrochlorideActive comparator 1 intervention
Group C: dexmedetomidine hydrochloride and ketamine hydrochlorideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Day 1 Postoperative morphine requirement

Cumulative dose of morphine used by the patient

Time frame
Day 1

Secondary outcomes

1

day 2 Postoperativve morphine requirement

cumulative dose of morphine used by the patient

Time frame
day 2
2

Pain score at rest 24h

Pain score (Verbal Numeric Scale (0-10) at rest

Time frame
day 1
3

Pain score at rest 48h

Pain score (Verbal Numeric Scale (0-10) at rest

Time frame
day 2
4

Pain score at cough 24h

Pain score (Verbal Numeric Scale (0-10) at cough

Time frame
day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

Maisonneuve-Rosemont Hospital

Sponsor institution

Source ClinicalTrials.gov
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