Effect of Subanaesthetic Dose of Ketamine on Depth of Anaesthesia Consistency

NCT06986109 | Recruiting DMC

• 1 other identifier: EC/03/25/2670
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anesthesia

Keywords

ketamine; propofol; Bi-spectral index; closed-loop anaesthesia delivery system

Outcome Measures

Primary Outcomes (1)

• Anaesthesia depth consistency

  It will be determined by the percentage of the anaesthesia time during which the BIS remained +/- 10 of the target BIS of 50

  During the surgical procedure, an average of 360 minutes

Secondary Outcomes (13)

• Performance characteristic of propofol delivery system determined by calculating the median performance error (MDPE)

  During the surgical procedure, an average of 360 minutes

• Performance characteristic of propofol delivery system determined by calculating the median absolute performance error (MDAPE)

  During the surgical procedure, an average of 360 minutes

• Performance characteristic of propofol delivery system determined by calculating the wobble

  During the surgical procedure, an average of 360 minutes

• Performance characteristic of propofol delivery system determined by calculating the global score

  During the surgical procedure, an average of 360 minutes

• Propofol induction dose (mg/kg)

  From start of propofol injection till target BIS value of '50' is achieved, an average of 5 minutes after beginning of anesthesia

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

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.

Drug: Ketamine; Drug: Propofol

Placebo Group

ACTIVE COMPARATOR

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.

Drug: Propofol; Drug: Placebo

Interventions

Ketamine DRUG

Ketamine (concentration 5mg/ml) will be administered at 0.05-ml/kg over 5-minutes followed by continuous intraoperative ketamine infusion of 0.05-ml/kg /h.

Ketamine Group

Propofol DRUG

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the conventional closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.

Ketamine Group; Placebo Group

Placebo DRUG

Normal saline bolus 0.05-ml/kg will be administered over 5-minutes and it will be followed by continuous intraoperative normal saline infusion at 0.05-ml/kg /h.

Placebo Group

Eligibility Criteria

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

You may qualify if:

• ASA physical status I and II.
• Patients scheduled for elective laparoscopic surgery with estimated duration greater than 60-minutes.

You may not qualify if:

• Known uncontrolled cardiovascular disease (e.g., hypertension, systolic and diastolic dysfunction)
• Liver function abnormality (liver enzymes \>2 times the normal range)
• Kidney function abnormality (serum creatinine \>1.4 mg/dl)
• Known psychiatric or neurological disorder
• Known uncontrolled endocrine disorder (diabetes mellitus, hypothyroidism)
• Known allergy or hypersensitivity to the study drug
• Recent intake of sedative medication or anti-psychotic medication
• Substance abuse
• Anticipated need for postoperative ventilation
• Refusal to informed consent

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

RECRUITING

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

• Amitabh Dutta, MD, PGDHR

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY DIRECTOR

Central Study Contacts

Nitin Sethi, DNB

CONTACT

00919717494498; nitinsethi77@yahoo.co.in

Sanah Mahajan, MBBS

CONTACT

00918082810116; sanahmahajan26@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study drugs will be prepared by an independent investigator not involved in the conduct of case. Both the drugs will be administered as a bolus of 0.05-ml/kg followed by intraoperative infusion of 0.05-ml/kg/h. The investigator conducting the case and the patient will be blinded to the allocated intervention. The postoperative follow up of the patients will be done by an independent investigator who will be neither involved in the preparation of the study drugs or the conduct of the case.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: One hundred and six participants (53/group) aged 18-65 years, ASA physical status I-II, of either sex, and undergoing elective laparosocpic surgery will be randomly divided into one of the two groups: Group I: Ketamine Group Prior to anaesthesia induction, a bolus dose of ketamine solution 0.05-ml/kg (concentration 5mg/ml) will be administered followed by continuous intraoperative ketamine infusion of 0.05-ml/kg /h along with automated propofol TIVA delivered using CLADS. Group II: Placebo Group Prior to anaesthesia induction, an equivalent volume bolus (0.05-ml/kg) of 0.9% normal saline will be administered and it will be followed by continuous intraoperative 0.9% normal saline infusion at 0.05-ml/kg /h along with automated propofol TIVA delivered using CLADS.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 22, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

IN (1)