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Trial record 3 of 837 for:    Ketamine

Comparison of BIS Index Variations: Bolus Versus Infusion Ketamine, and Impact on the Anesthesia Gas Consumption (KETABIS)

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ClinicalTrials.gov Identifier: NCT03781635
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Philippe Richebe, Ciusss de L'Est de l'Île de Montréal

Brief Summary:
The aim of the present study is to show that i.v. ketamine boluses might lead to significant and clinically relevant BIS index increase that might lead to an increase in anesthesia dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any bolus.

Condition or disease Intervention/treatment Phase
Bolus Versus Infusion Ketamine, Anesthesia Gas Consumption Drug: bolus of intravenous ketamine Drug: continuous infusion of intravenous ketamine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of patients. Randomization into group infusion versus boluses of ketamine according to a randomization list for a total number of patients of 50.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization into group infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of the surgery
Primary Purpose: Treatment
Official Title: Comparison of BIS Index Variations When i.v. Low-dose Ketamine is Administered Intraoperatively as Bolus Versus Continuous Infusion and Impact on the Anesthesia Gas Consumption.
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: bolus of intravenous ketamine
A bolus of 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at incision (T0) for ketamine administration and ends when the surgical team starts closing the deep layers of the abdominal incision.
Drug: bolus of intravenous ketamine
low-dose ketamine (0.25mg.kg-1) is administered intraoperatively as bolus at incision (T0) and for each hour of anesthesia untel the end of surgery.

Experimental: continuous infusion of intravenous ketamine
An infusion of 0.25 mg.kg-1.h-1 is started at T0 (incision) with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery until the infusion is discontinued.
Drug: continuous infusion of intravenous ketamine
An infusion of low-dose ketamine (0.25 mg.kg-1.h-1) is started at T0 (incision) with an infusion pump and is kept at the same rate until the end of surgery




Primary Outcome Measures :
  1. Evaluation of the increase of the BIS index (absolute value between 0 to 100) after each intravenous ketamine bolus [ Time Frame: Intraoperative, during anesthesia ]
    To demonstrate and quantify à significant increase of the BIS index after each bolus of 0.25 mg.kg-1 ketamine given during surgeries lasting 3 hours and more, compared to an equivalent dose of ketamine given as a continuous infusion. Boluses of ketamine will start at T0 = incision and then will be repeated every hour for the duration of the surgery.


Secondary Outcome Measures :
  1. Area under the curve of BIS values from T0=incision until end of the anesthesia, value without unit (area under curve) [ Time Frame: Intraoperative, during anesthesia ]
    To compare the BIS index values area under the curve from T0=incision until end of anesthesia when i.v. ketamine 0.25mg.kg-1.h-1 is administered as an infusion or as hourly boluses.

  2. Time for BIS to return within 10% of the baseline values (in minutes) [ Time Frame: Intraoperative, during anesthesia ]
    To evaluate the time in minutes for the BIS index values to return within +/-10% of the values the BIS index had before the bolus of ketamine.

  3. Time to reach the peak of BIS index after intravenous bolus of ketamine [ Time Frame: Intraoperative, during anesthesia ]
    To evaluate the time in seconds at which the peak of BIS will occur after intravenous ketamine bolus 0.25mg/kg.

  4. Evaluation of the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h of gas [ Time Frame: Intraoperative, during anesthesia ]
    To evaluate the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h.

  5. Evaluation of the consumption of phenylephrine in mcg/kg/h for each hour of anesthesia. [ Time Frame: Intraoperative, during anesthesia ]
    To evaluate the need of intravenous phenylephrine given during each hour of anesthesia in both groups.

  6. Evaluation of the blood pressure during each hour of anesthesia. [ Time Frame: Intraoperative, during anesthesia ]
    To evaluate blood pressure recorded electronically during the whole anesthesia and to evaluate the impact of intravenous bolus of ketamine 0.25mg/kg on blood pressure during the whole hour following each bolus administration (given hourly).

  7. Evaluation of the time in minutes necessary to extubatne the patient at the end of the surgery [ Time Frame: End of surgery ]
    To evaluate the time for extubation in minutes at the end of surgery

  8. Evaluation of the time in minutes to reach an Alerte score of >9 in post-anesthesia care unit [ Time Frame: In post anesthesia care unit, 2 hours after surgery is done ]
    To evaluate the time in minutes to reach an alerte score (this score has no unit) of more than 9.

  9. Evaluation of the MOCA score (score from 0 to 30) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit) [ Time Frame: 15 minutes after arrival in PACU ]
    To evaluate the MOCA score (0 to 30) in PACU at 15minutes after arrival.

  10. Evaluation of the MOCA score (score from 0 to 30) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit) [ Time Frame: 45 minutes after arrival in PACU ]
    To evaluate the MOCA score (0 to 30) in PACU at 45minutes after arrival.

  11. Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit) [ Time Frame: 15 minutes after arrival in PACU ]
    To evaluate the CAM (no unit) in PACU at 15minutes after arrival.

  12. Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit) [ Time Frame: 45 minutes after arrival in PACU ]
    To evaluate the CAM (no unit) in PACU at 45minutes after arrival.

  13. Evaluation of the total time spent in PACU in minutes [ Time Frame: 3 hours after surgery ]
    Total time in PACU in minutes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I to III
  • Patients above 18yo
  • Gender female or male
  • Abdominal general, urological or gynecological surgery with epidural placement

Exclusion Criteria:

  • BMI <18 or >35
  • Chronic neurological or psychiatric disorder or history of stroke
  • Use of psychotropic drugs within 2 weeks prior surgery
  • Allergy to ketamine or its excipients or any drug of the anesthesia protocol of this study
  • Any contra-indication or patient's refusal for epidural placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781635


Contacts
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Contact: Philippe PR Richebé, MD PhD 514-743-6558 philippe.richebe@umontreal.ca
Contact: Nadia NG Godin, RC and RN 514-525-3400 ext 3193 ngodin.hmr@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal Recruiting
Montréal-Est, Quebec, Canada, H1T2M4
Contact: Nadia NG Godin, RC and RN    514-252-3400 ext 3193    ngodin.hmr@ssss.gouv.qc.ca   
Contact: Philippe PR Richebe, MD PhD    514-252-3400 ext 4620    philipperichebe@live.com   
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Investigators
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Principal Investigator: Philippe PR Richebé, MD PhD CIUSSS Est de l'ile de Montreal

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Responsible Party: Philippe Richebe, MD, PhD, Professor, Director of Research, Department of Anesthesiology and Pain Medicine of Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT03781635     History of Changes
Other Study ID Numbers: 2018-1482
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Philippe Richebe, Ciusss de L'Est de l'Île de Montréal:
Ketamine
anesthesia
BIS monitoring
epidural
intraoperative

Additional relevant MeSH terms:
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Ketamine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action