Effect of Gender on Propofol Requirement

NCT05725135 | Completed

• 1 other identifier: EC/01/23/2217
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Total intravenous anaesthesia (TIVA) has emerged as a viable alternative to inhalational general anaesthesia (GA). Propofol is the preferred drug for providing TIVA due to its favorable pharmacokinetic profile, such as, rapid onset of action and a short context sensitivity half -life. There is suggestion that consumption of Propofol required during TIVA is influenced by gender with females requiring higher dose due to higher volume of distribution of drug. The evidence on gender differences in Propofol requirement for TIVA is largely based on studies done using subjective (manual titration of infusions)/semi-objective (target-controlled infusions) methods of drug administration, whose initial setting and ongoing control may be affected by attending anesthesiologist discretion and action. A recent advance in Propofol TIVA delivery is development of objective automated anaesthesia delivery systems. These systems administer Propofol titrated to patients' electroencephalogram (EEG) response reflected by processed EEG monitoring, namely the Bispectral index (BIS). One such indigenously developed automated anaesthesia delivery system is the closed-loop anaesthesia delivery system (CLADS). CLADS is a more precise and robust system to facilitate administration of Propofol TIVA, which automatically regulates the dose of medication based on feedback from patient's BIS data. The present study proposes to explore if there can be any gender differences in Propofol requirements during total intravenous anaesthesia administered by CLADS. All patients undergoing elective surgery under Propofol TIVA using CLADS will be screened, and those eligible will be enrolled. Enrolled patients will receive automated Propofol TIVA using CLADS. Demographic and clinical details including gender of patient will be noted. Cumulative dose of Propofol use will be computed through algorithm executed and monitored by software built into the CLADS. The findings will then be compared between male and female gender. Other intraoperative and post- operative outcomes such as time-to-loss of consciousness, time-to-induction of anaesthesia, anaesthesia depth consistency, performance characteristic of CLADS, hemodynamic profile (heart rate, mean arterial blood pressure), time-to-early recovery from anaesthesia, and postoperative sedation scale (modified observers' assessment of alertness/sedation scale \[MOAA/S\]); will be noted and compared between males and females. We expect to enroll 80 patients in our study.

Conditions

Anesthesia

Keywords

propofol; male; female

Outcome Measures

Primary Outcomes (1)

• Cumulative Propofol consumption (mg/kg/h) during anaesthesia

  Dose of Propofol required for induction and maintenance of anesthesia

  From start of Propofol injection 10-hours intraoperatively]

Secondary Outcomes (12)

• Time to loss of consciousness

  From start of anesthesia till 5- minutes intraoperatively

• Time to induction of anaesthesia

  From start of anesthesia till 5- minutes intraoperatively

• Intra-operative heart rate (beats per minute)

  From beginning of anesthesia till 10 hours intraoperatively

• Intra-operative systolic , diastolic, and mean blood pressure (mmHg)

  From beginning of anesthesia till 10 hours intraoperatively

• Anesthesia depth consistency

  From beginning of anesthesia till 10 hours intraoperatively

Study Arms (2)

Males

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

Drug: Propofol

Females

Propofol total intravenous anaesthesia (TIVA) will be used for both induction and maintenance of anaesthesia. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using automated closed-loop anesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesi

Drug: Propofol

Interventions

Propofol DRUG

Propofol total intravenous anesthesia (TIVA) will be used for induction and maintenance of anesthesia. Propofol will be delivered using automated closed-loop anesthesia delivery system.

Females; Males

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery requiring general anesthesia

You may qualify if:

• Age 18-60 years.
• ASA physical status I and II.
• Patients undergoing elective surgeries of minimum 1 hour duration.

You may not qualify if:

• Uncompensated cardiovascular disease (e.g., uncontrolled hypertension, systolic and diastolic dysfunction)
• Hepatic dysfunction (liver enzymes \> 2 times the normal range)
• Renal dysfunction (serum creatinine \> 1.4 mg/dl)
• Psychiatric or neurological disorder
• Uncontrolled endocrinology disease (diabetes mellitus, hypothyroidism)
• Known allergy/hypersensitivity to the study drug
• History of recent intake of sedative medication or anti-psychotic medication
• Drug dependence/substance abuse
• Requirement of 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

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Amitabh Dutta, MD, PGDHR

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY DIRECTOR

• Jayashree Sood, MD, FFRCA, PGDHHM, FICA

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 15, 2023
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IN (1)