CholecystectomyNCT06473896
Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil
A study testing Ketalar and Dexmedetomidine in people with Cholecystectomy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Ketalar and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Apr 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir (Asaf Harofe) Medical Center
Be’er Ya‘aqov, 70300
Sara Bar Yehuda, PhD, 972528981004, sarabar1@shamur.gov.il
Zoya Haitov Ben Zikri, MD, 972537346186, ZoyaC@shamir.gov.il
About this study
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
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
Read the 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.
- Conditions
- Cholecystectomy
- Being tested
- Ketalar, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetalarDrug
Also called Ketamine
a dissociative anesthetic used medically for induction and maintenance of anesthesia
DexmedetomidineDrug
Also called Precedex
an agonist of α2-adrenergic receptors in certain parts of the brain used for sedation
| Study group | Role | What they receive |
|---|---|---|
| Ketalar | Active comparator | All patients will undergo general anesthesia using Fentanyl at a dose of 2 mcg/kg, Rocuronium at a dose of 0.6 mg/kg, Isoflurane during surgery and Remifentanil at a dose of 0.2-0.25 mcg/kg/min, 30 Minutes before the end of the operation, Morphine will be given at a dose of 0.1 mg/kg. Each patient will receive paracetamol during surgery.
In addition to the general anesthesia, the patients in the Ketalar group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute. Receives: Drug: Ketalar |
| Dexmedetomidine | Active comparator | In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute.
In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Dexmedetomidine at a dose of 0.5 mg/kg for fifteen minutes + Propofol and Fentanyl, and during the operation, continuous Dexmedetomidine at a dose of 0.3 mcg/kg/hour. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Up to two hours after the end of the anesthesia process
Pain killer consumption
Treatment with morphine for pain relief
Measured: Up to two hours after the end of the anesthesia process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start18 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center
- Investigators
- Sara Bar Yehuda, PhD, Study director, Shamir (Asaf Harofe) medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473896
- Sponsor's protocol ID
- 0173-23-ASF
- Status last verified
- Aug 2024
- First submitted
- 19 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be = will be provided as needed after receiving approval from the authorities of the Shamir (Asaf Harofe) medical center
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06473896
- Acronym / sponsor ID
- 0173-23-ASF
- Conditions
- Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Ketalar | Active comparator | Drug: KetalarAll patients will undergo general anesthesia using Fentanyl at a dose of 2 mcg/kg, Rocuronium at a dose of 0.6 mg/kg, Isoflurane during surgery and Remifentanil at a dose of 0.2-0.25 mcg/kg/min, 30 Minutes before the end of the operation, Morphine will be given at a dose of 0.1 mg/kg. Each patient will receive paracetamol during surgery. In addition to the general anesthesia, the patients in the Ketalar group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute. |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineIn addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute. In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Dexmedetomidine at a dose of 0.5 mg/kg for fifteen minutes + Propofol and Fentanyl, and during the operation, continuous Dexmedetomidine at a dose of 0.3 mcg/kg/hour. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetalarAlso: Ketaminea dissociative anesthetic used medically for induction and maintenance of anesthesia | Drug | Ketalar |
| DexmedetomidineAlso: Precedexan agonist of α2-adrenergic receptors in certain parts of the brain used for sedation | Drug | Dexmedetomidine |
Primary outcome
Pain Level
Time frame: 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
Time frame: Up to two hours after the end of the anesthesia process
Treatment with morphine for pain relief
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided. IPD will be = will be provided as needed after receiving approval from the authorities of the Shamir (Asaf Harofe) medical center
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Bar Yehuda, PhD study director
Shamir (Asaf Harofe) medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketalar and Dexmedetomidine in people with Cholecystectomy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Bar Yehuda, PhD (972528981004, sarabar1@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Up to two hours after the end of the anesthesia process). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.