Recruiting

Dexmedetomidine & Ketamine

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT03596424

Conditions

Postoperative Pain

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Dexmedetomidine Hydrochloride

dexmedetomidine Hydrochloride and Ketamine Hydrochloride

Study Details

Brief summary:

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.

Conditions

Postoperative Pain

Opioid Use

Study ID

NCT03596424

Start date

Feb 1, 2018

Status verified date

Nov, 2024

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients aged 18-80 years old
  • American Society of Anesthesiology physical status I-III
  • Elective Video-Assisted Thoracic Surgery for pulmonary resection

Exclusion Criteria:

  • 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.
  • Documented allergy to ketamine and/or dexmedetomidine.
  • Pregnancy
  • Inability to give informed consent
  • Linguistic barrier.
  • Patient refusal

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Ketamine hydrochloride

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;

active comparator: dexmedetomidine hydrochloride

Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5µg/kg/h) of dexmedetomidine plus an intraoperative bolus and infusion of normal saline

active comparator: dexmedetomidine hydrochloride and ketamine hydrochloride

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

Interventions

Ketamine Hydrochloride

Intraoperative bolus and infusion (see arm description)

Dexmedetomidine Hydrochloride

Intraoperative bolus and infusion (see arm description)

dexmedetomidine Hydrochloride and Ketamine Hydrochloride

Intraoperative bolus and infusion (see arm description)

Primary outcome measure

  • Day 1 Postoperative morphine requirement [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Veronique Brulotte, MD

5142523400veronique.brulotte@umontreal.ca

Nadia Godin, RN

5142523400

Locations

Ciusss

Recruiting

Montréal, Quebec, Canada, H1T2M4

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Dec 2, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-12-02.