Ketamine Effect on Isoflurane Anesthesia

NCT03290495 | Completed Phase 4

• 1 other identifier: isoflurane ketamine gamma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-anesthesia Recovery

Keywords

ketamine; isoflurane; electroencephalography; maintenance; recovery; anesthesia

Outcome Measures

Primary Outcomes (1)

• recovery time

  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.

  Time Frame: 1 hour

Secondary Outcomes (2)

• gamma wave activity

  Time Frame: 2 hour

• processed EEG parameters

  Time Frame: 2 hour

Study Arms (2)

isonly

ACTIVE COMPARATOR

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

isoket

ACTIVE COMPARATOR

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

Interventions

ketamine DRUG

ketamine hydrochloride 250microgram/ ml for iv injection after 30 minutes of stable isoflurane anesthesia

Also known as: Calypsol

isoket

saline DRUG

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.

Also known as: normal saline, Atsuka

isonly

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital (main hospital)-kornish elnil st.

Minya, Minya Governorate, 61511, Egypt

Location

Related Publications (5)

• Li D, Hambrecht-Wiedbusch VS, Mashour GA. Accelerated Recovery of Consciousness after General Anesthesia Is Associated with Increased Functional Brain Connectivity in the High-Gamma Bandwidth. Front Syst Neurosci. 2017 Mar 24;11:16. doi: 10.3389/fnsys.2017.00016. eCollection 2017.

  PMID: 28392760 BACKGROUND

• Mashour GA. Cognitive unbinding: a neuroscientific paradigm of general anesthesia and related states of unconsciousness. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2751-9. doi: 10.1016/j.neubiorev.2013.09.009. Epub 2013 Sep 26.

  PMID: 24076246 BACKGROUND

• Philip BK, Kallar SK, Bogetz MS, Scheller MS, Wetchler BV. A multicenter comparison of maintenance and recovery with sevoflurane or isoflurane for adult ambulatory anesthesia. The Sevoflurane Multicenter Ambulatory Group. Anesth Analg. 1996 Aug;83(2):314-9. doi: 10.1097/00000539-199608000-00019.

  PMID: 8694311 BACKGROUND

• Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995 Oct 28;311(7013):1145-8. doi: 10.1136/bmj.311.7013.1145.

  PMID: 7580713 BACKGROUND

• Florey CD. Sample size for beginners. BMJ. 1993 May 1;306(6886):1181-4. doi: 10.1136/bmj.306.6886.1181.

  PMID: 8499826 BACKGROUND

MeSH Terms

Interventions

Ketamine; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mamdouh H Hassan, MD

  Minia faculty of Medicine. Minia university. Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 25, 2017
• Study Start: September 30, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 25, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

EG (1)