Effect of Subanaesthetic Dose of Ketamine on Depth of Anaesthesia Consistency During Propofol Total Intravenous Anaesthesia Administered by Closed-loop Anaesthesia Delivery System in Adults Undergoing Elective Laparoscopic Surgery: a Randomised Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

General Anaesthesia (GA) is a medical state of controlled unconsciousness that inhibits two dimensions of consciousness: the content and the level of consciousness. This state is achieved using various anaesthetic agents, with propofol being one of the most commonly used intravenous anaesthetics. Propofol is a gamma amino butyric acid (GABAA) receptor agonist, which affects both the content and level of anaesthesia. In some cases, anaesthesiologists may choose to use an adjuvant drug, ketamine, in subanaesthetic doses during inhalation GA and propofol total intravenous anaesthesia (TIVA). Ketamine is an N-methyl D-aspartate (NMDA) receptor antagonist and is primarily employed for its analgesic properties. Unlike propofol, ketamine selectively affects only the content of consciousness. The combination of propofol and ketamine appears to have dual effects on the dimensions of consciousness, with propofol affecting both content and level, and ketamine affecting only the content. This combination is likely to complement and improve the consistency of intraoperative anaesthesia depth. However, studies have shown that the administration of ketamine with propofol TIVA, delivered through an automated anaesthesia delivery system using electroencephalogram (EEG) feedback signals from NeuroSENSE processed electroencephalogram (pEEG) monitor, has not demonstrated any significant benefit over the use of propofol alone. Till now, the only study on propofol-ketamine co-administration used an uncommon NeuroSENSE pEEG monitoring system. Closed loop anaesthesia delivery system (CLADS) is a more precise, efficient, and robust mechanism to facilitate automated administration of propofol TIVA which employs the standard bispectral index (BIS) pEEG monitoring to control propofol TIVA delivery. Further evidence is desirable on depth of anaesthesia consistency when ketamine is co-administered with propofol TIVA, using CLADS This randomised controlled study will compare the effect of subanaesthetic dose of ketamine versus placebo (normal saline) on anaesthesia depth consistency in patients undergoing elective laparoscopic surgery under automated propofol TIVA using CLADS. All patients undergoing elective laparoscopic surgery will be screened, and those found eligible will be enrolled. Enrolled patients will receive CLADS-controlled propofol TIVA as standard. In intervention are, patients will additionally receive subanaesthetic dose of ketamine (0.25-mg/kg bolus followed by maintenance infusion 0.25-mg/kg/h) (ketamine group); in control arm, patients will receive normal saline as placebo in addition to propofol TIVA (placebo group).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• ASA physical status I and II.

• Patients scheduled for elective laparoscopic surgery with estimated duration greater than 60-minutes.

Locations
Other Locations
India
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Contact Information
Primary
Nitin Sethi, DNB
nitinsethi77@yahoo.co.in
00919717494498
Backup
Sanah Mahajan, MBBS
sanahmahajan26@gmail.com
00918082810116
Time Frame
Start Date: 2025-05-26
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 106
Treatments
Active_comparator: Ketamine Group
100 mg of ketamine will be diluted in 20 ml of normal saline to make a ketamine concentration of 5mg/ml. Patients will receive a pre-induction bolus of ketamine solution at 0.05-ml/kg administered over 5-minutes and followed by maintenance infusion rate of 0.05-ml/kg /h throughout the duration of surgery. Anaesthesia induction and maintenance will be carried with propofol delivered and controlled by closed-loop anaesthesia delivery system (CLADS) a BIS-based feedback-loop automated anaesthesia delivery system. A target BIS value of '50' will be considered adequate for both induction and maintenance of anaesthesia.
Active_comparator: Placebo Group
20-ml of normal saline will be taken and an equivalent volume will be used with a pre-induction bolus of 0.05-ml/kg administered over 5-minutes and followed by maintenance infusion rate of 0.05-ml/kg /h throughout the duration of surgery.Anaesthesia induction and maintenance will be carried with propofol delivered and controlled by closed-loop anaesthesia delivery system (CLADS) a BIS-based feedback-loop automated anaesthesia delivery system. A target BIS value of '50' will be considered adequate for both induction and maintenance of anaesthesia.
Related Therapeutic Areas
Sponsors
Leads: Sir Ganga Ram Hospital

This content was sourced from clinicaltrials.gov