Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil

Assaf-Harofeh Medical Center90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cholecystectomy

Interventions

KetalarDRUG

a dissociative anesthetic used medically for induction and maintenance of anesthesia

DexmedetomidineDRUG

an agonist of α2-adrenergic receptors in certain parts of the brain used for sedation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, Israel

RECRUITING

Outcomes

Primary Outcomes

Pain Level

A record of pain level will be made using the Visual Analogue Scale. The score is determined by marking on 10-cm line between 0 - "no pain" to 10 - "the highest pain".

Time frame: Up to two hours after the end of the anesthesia process

Pain killer consumption

Treatment with morphine for pain relief

Time frame: Up to two hours after the end of the anesthesia process

Central Contacts

Sara Bar Yehuda, PhD

CONTACT

972528981004 sarabar1@shamir.gov.il

Zoya Haitov Ben Zikri, MD

CONTACT

972537346186 ZoyaC@shamir.gov.il

Data from ClinicalTrials.gov

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