Cholecystectomy
Conditions
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.
Interventions
DRUGKetalar
a dissociative anesthetic used medically for induction and maintenance of anesthesia
DRUGDexmedetomidine
an agonist of α2-adrenergic receptors in certain parts of the brain used for sedation
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patients will not be exposed to the treatment arm they will receive
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | Up to two hours after the end of the anesthesia process | 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. |
| Pain killer consumption | Up to two hours after the end of the anesthesia process | Treatment with morphine for pain relief |
Countries
Israel
Contacts
Primary ContactSara Bar Yehuda, PhD
Backup ContactZoya Haitov Ben Zikri, MD
Outcome results
None listed