Clinical trial

Impact of Dexmedetomidine and Ketamine and Their Combination for the Reduction of Postoperative Morphine Requirements After VATS Surgery

Name
DexketVATS
Description
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.
Trial arms
Trial start
2018-02-01
Estimated PCD
2024-12-01
Trial end
2025-07-01
Status
Recruiting
Treatment
Ketamine Hydrochloride
Intraoperative bolus and infusion (see arm description)
Arms:
Ketamine hydrochloride
Other names:
ketamine
Dexmedetomidine Hydrochloride
Intraoperative bolus and infusion (see arm description)
Arms:
dexmedetomidine hydrochloride
Other names:
dexmedetomidine
dexmedetomidine Hydrochloride and Ketamine Hydrochloride
Intraoperative bolus and infusion (see arm description)
Arms:
dexmedetomidine hydrochloride and ketamine hydrochloride
Other names:
dexmedetomidine and ketamine
Size
120
Primary endpoint
Day 1 Postoperative morphine requirement
Day 1
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-08-30

1 organization

2 products

1 drug

2 indications

Indication
Opioid Use