Clinical trial NCT06473896: Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil
Official title: Comparison of the Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Induced Following Treatment With Remifentanil in Patients Undergoing a Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholecystectomy
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-06-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be classified into 2 groups:

The Ketalar group - who will receive, in addition to the general anesthesia, a bolus of Ketalar during induction and during the operation, continuous ketamine.

The Dexmedetomidine group - in addition to the general anesthesia, they will also receive a Dexmedetomidine bolus in the induction and during the operation continuous Dexmedetomidine
Primary purpose: TREATMENT

Brief summary: Analgesia is one of the pillars of anesthesia. One of the common opiates for pain relief, with a short half-life, is Remifentanil. However, following Remifentanil treatment an increased sensitivity to pain \[hyperalgesia\] appears. The aim of the study is to compare the effects between complementary treatments, like Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain after Remifentanil treatment

Detailed description: Analgesia is one of the pillars of anesthesia. For many years, opiates were the basic ingredient in pain relief. The effectiveness of these substances in pain relief caused them to be overused which resulted in a global epidemic of addiction, morbidity and mortality due to the overuse of these drugs. Some of the options for realizing a reduction in the use of opiates include the use of drugs with a more predictable pharmacological profile and a short half-life, such as Remifentanil. This opiate is stronger than Morphine and its half-life remains within a few minutes, without accumulation even after prolonged infusion. Therefore, it seems that the use of remifentanil is ideal, especially for prolonged anesthesia.

One of the severe complications following treatment with Remifentanil is the appearance of increased sensitivity to pain \[hyperalgesia\] which results from a central sensitivity to pain and is expressed by stimulation of sensory receptors for pain in the nervous system (nociceptive sensitization). In order to alleviate the feeling of pain following the increased sensitivity to pain after treatment with opiates, as well as with Remifentanil, complementary treatments, such as Ketalar and dexmedetomidine, were offered. This study will compare the ability of Ketalar or Dexmedetomidine in alleviating increased sensitivity to pain after treatment with Remifentanil in patients who are candidates for laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

• Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* 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/liver function problems

Primary outcomes:
measure: Pain Level
timeFrame: Up to two hours after the end of the anesthesia process
measure: Pain killer consumption
timeFrame: Up to two hours after the end of the anesthesia process
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir (Asaf Harofe) Medical Center
Study officials:
affiliation: Shamir (Asaf Harofe) medical center
name: Sara Bar Yehuda, PhD
role: STUDY_DIRECTOR
References: