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Ketamine Effect on Isoflurane Anesthesia

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ClinicalTrials.gov Identifier: NCT03290495
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hassan, Mamdouh Hassan Mohamed, Minia University

Brief Summary:

Ketamine effect on isoflurane anesthesia This study is designed to study the effect of ketamine on isoflurane anesthesia. As both drugs are hypnotic and are used to cause sleep during surgery and other painful procedures, it was long believed that the actions of two drugs add to each other. For example if a man received both drugs, this man will become awake from anesthesia much later than if this man was given either of them alone.

However recent studies showed that this is not the case and ketamine can cause fast recovery from hypnotic effects of isoflurane. This was confirmed in animals.

The aim of current study is to investigate if this effect applies for humans, using a state of art brain monitoring device in wide use nowadays called BIS or bispectral index. This device can also shed some light on how ketamine can cause, if any, fast recovery from isoflurane anesthesia. Simply, by studying electrical wave coming from brain to head skin.


Condition or disease Intervention/treatment Phase
Post-anesthesia Recovery Drug: ketamine Drug: saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

An intravenous catheter was placed and normal saline (0.9%) will be infused. Spinal anesthesia will be given. The stability of spinal anesthesia will be assured before propofol injection and at the end of procedure.

Propofol will be given to facilitate isoflurane inhalation which will be varied between 0.8-1.2percent to keep (BIS) in the range 40-60. Anesthesia will be kept as so for 30 minutes. Then the test drug (either ketamine or saline) will be given slowly, to pressor response in case of ketamine. Anesthesia will be maintained for another 30 minutes then isoflurane is discontinued. Recovery from anesthesia will then be tested.. No other drugs will be routinely given. Development of complications or signs of inadequate anesthesia will cause drop of the case from study and any measures will be taken to insure patient safety and comfort.The patient will be let to recover from anesthesia then transferred to postoperative care unit.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The patients well be randomized to one of the two groups by closed envelope technique. After opening the envelope, the study drug (ketamine 100µg/kg total body weight (Isoket group)) or normal saline ((Isonly) or control group) will be prepared, made up to 10 ml and administered by an assistant in the proper timing. The patient identification will be written on a slip and put back into an envelope and sealed. The person doing the procedure and monitoring along with the patient will be blinded to the dose and nature of solution. The equal volume test solution will be given intravenously by an assistant who was not involved in the administration of anesthesia and monitoring
Primary Purpose: Basic Science
Official Title: Electroencephalographic Effects of Ketamine During Isoflurane Maintenance and Recovery
Actual Study Start Date : September 30, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: isonly
This arm will receive spinal anesthesia. then this arm will receive saline during isoflurane anesthesia. this arm will serve as a control group.
Drug: saline
a similar volume of normal saline 0.9% for intravenous injection instead of ketamine will be given to the control group. this because the attending anesthesiologist will be blinded to the study drugs and aim according to the study proposal.
Other Name: normal saline, Atsuka

Active Comparator: isoket
this arm will receive spinal anesthesia. then will receive isoflurane inhalation. during isoflurane inhalation, this arm will receive single injection of ketamine. at end of anesthesia, effect of ketamine on recovery will be monitored.
Drug: ketamine
ketamine hydrochloride 250microgram/ ml for iv injection after 30 minutes of stable isoflurane anesthesia
Other Name: Calypsol




Primary Outcome Measures :
  1. recovery time [ Time Frame: Time Frame: 1 hour ]
    recovery time in this study is defined as time between stop of isoflurane inhalation and recovery of consciousness . this will be assessed by calling the patient first name loudly until the patient verbally respond.time will be recorded in seconds.


Secondary Outcome Measures :
  1. gamma wave activity [ Time Frame: Time Frame: 2 hour ]
    EEG will recorded after test drug administration and during recovery. recorded data will be offline analysed for EEG wave activity. the results will be compared between the two study groups.

  2. processed EEG parameters [ Time Frame: Time Frame: 2 hour ]
    this include but not limited to BIS value, spectral edge frequency 95. these value will be online received from BIS monitor.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consent: patient must be legally fit to consent. Informed consent will be get from each patient.
  • ASA status: I or II.
  • Fully conscious at time of induction of anesthesia.
  • No history of side effects related to any drugs used in the study.
  • Planned surgery can be performed under spinal anesthesia

Exclusion Criteria:

  • Incompetence: failure to give informed consent or refusal.
  • Neurological or psychiatric disorders
  • Addiction
  • Recent intake of drugs affecting central nervous system
  • ASA state more than II
  • Morbid obesity
  • Surgery cannot solely performed under spinal anesthesia
  • Contraindication to spinal anesthesia as coagulopathy

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): NCT03290495


Locations
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Egypt
Minia University Hospital (main hospital)-kornish elnil st.
Al Minyā, Minya, Egypt, 61511
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Mamdouh H Hassan, MD Minia faculty of Medicine. Minia university. Egypt

Publications:
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Responsible Party: Hassan, Mamdouh Hassan Mohamed, lecturer of anesthesia and intensive care, Minia University
ClinicalTrials.gov Identifier: NCT03290495     History of Changes
Other Study ID Numbers: isoflurane ketamine gamma
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hassan, Mamdouh Hassan Mohamed, Minia University:
ketamine
isoflurane
electroencephalography
maintenance
recovery
anesthesia
Additional relevant MeSH terms:
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Ketamine
Anesthetics
Isoflurane
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
Anesthetics, Inhalation