Actively Recruiting
Comparison of Ketalar and Dexmedetomidine Effects on Pain Sensitivity After Remifentanil in Laparoscopic Cholecystectomy Patients
Led by Assaf-Harofeh Medical Center · Updated on 2024-08-07
90
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of two complementary treatments, Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain, known as hyperalgesia, following the use of Remifentanil during anesthesia. Remifentanil is an opioid pain reliever with a short half-life that is often used in prolonged anesthesia such as for laparoscopic cholecystectomy, but it can cause increased pain sensitivity after treatment. This study aims to compare how well Ketalar and Dexmedetomidine can reduce this pain sensitivity in patients undergoing this surgical procedure. All patients in the study will receive general anesthesia including Fentanyl, Rocuronium, Isoflurane, and Remifentanil, followed by Morphine and paracetamol during surgery. In addition, patients will be randomly assigned to receive either Ketalar, given as a bolus and continuous infusion during surgery alongside Propofol and Fentanyl, or Dexmedetomidine, given as a bolus over fifteen minutes and continuous infusion during surgery with Propofol and Fentanyl. The study compares these two treatments to assess their effect on pain after Remifentanil use. Participants will be monitored for pain levels and painkiller consumption up to two hours after anesthesia ends. Pain assessments and medication use will be recorded to evaluate how each treatment affects post-operative pain sensitivity. The study runs from April 2024 to August 2026 and includes adult patients undergoing laparoscopic gallbladder removal. Careful monitoring during and after surgery will help researchers understand the impact of these drugs on pain control and opioid-related sensitivity.
CONDITIONS
Brief Title
Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are about to undergo a laparoscopic cholecystectomy under general anesthesia
You will not qualify if you...
- Patients with sensitivity to the anesthetic
- Patients with chronic pain who are in regular treatment
- Urgent surgery
- Patients with ischemic heart disease
- Patients with known bradycardia
- Patients with a pacemaker
- Prolonged use of opiates
- Kidney or liver function problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgery and anesthesia
Participants undergo general anesthesia with Remifentanil during laparoscopic cholecystectomy and receive either Ketalar or Dexmedetomidine to study their effects on pain sensitivity after surgery.
1 surgery day visit (in-person)
Duration - Up to 2 hours after anesthesia
Participants are monitored for pain level and painkiller consumption for up to two hours after the end of anesthesia.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Shamir (Asaf Harofe) Medical Center
Be’er Ya‘aqov, Israel, 70300
Actively Recruiting
Research Team
S
Sara Bar Yehuda, PhD
Z
Zoya Haitov Ben Zikri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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