Dexmedetomidine and Ketamine in VATS Surgery

NCT03596424 | Recruiting DMC

• 1 other identifier: DexketVATS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Day 1 Postoperative morphine requirement

  Cumulative dose of morphine used by the patient

  Day 1

Secondary Outcomes (8)

• day 2 Postoperativve morphine requirement

  day 2

• Pain score at rest 24h

  day 1

• Pain score at rest 48h

  day 2

• Pain score at cough 24h

  day 1

• Pain score at cough 48h

  day 2

Study Arms (3)

Ketamine hydrochloride

ACTIVE COMPARATOR

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;

Drug: Ketamine Hydrochloride

dexmedetomidine hydrochloride

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine Hydrochloride

dexmedetomidine hydrochloride and ketamine hydrochloride

ACTIVE COMPARATOR

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

Combination Product: dexmedetomidine Hydrochloride and Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

Intraoperative bolus and infusion (see arm description)

Also known as: ketamine

Ketamine hydrochloride

Dexmedetomidine Hydrochloride DRUG

Intraoperative bolus and infusion (see arm description)

Also known as: dexmedetomidine

dexmedetomidine hydrochloride

dexmedetomidine Hydrochloride and Ketamine Hydrochloride COMBINATION_PRODUCT

Intraoperative bolus and infusion (see arm description)

Also known as: dexmedetomidine and ketamine

dexmedetomidine hydrochloride and ketamine hydrochloride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Ciusss

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Veronique Brulotte, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique Brulotte, MD

CONTACT

5142523400; veronique.brulotte@umontreal.ca

Nadia Godin, RN

CONTACT

5142523400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 27, 2018
• First Posted: July 23, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)