- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05725135
Effect of Gender on Propofol Requirement
Gender Differences in Propofol Requirements During Total Intravenous Anaesthesia Administered by Closed-loop Anaesthesia Delivery System: An Observational Study
Study Overview
Detailed Description
Total intravenous anaesthesia (TIVA) has emerged as a viable alternative to inhalational general anaesthesia (GA). Progress into TIVA is much desirable for continued development of precision GA. To this effect, Propofol is a key intravenous agent because of its favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile and broad administration applicability with different methods of delivery: manual and target-controlled infusion [TCI].
The evidence on gender differences during manual/TCI Propofol TIVA suggests that females as compared to males have increased requirement of Propofol and yet have a faster time to recovery from anaesthesia. A 5-10% excess body fat and 15-20% decreased water content in females as compared to males' results in an increase in volume of distribution (Vd) of lipophilic drugs (e.g., Propofol), which consequently necessitates a higher rate of delivery of the Propofol infusion to achieve the same plasma concentration (as males) for clinically acceptable depth-of-anaesthesia. Whereas an increased Propofol sensitivity results in early awakening from anaesthesia.
The studies on gender differences in Propofol requirements and recovery from anaesthesia are largely based on semi-objective methods of Propofol TIVA administration (manual/TCI). The human element in titration and control of manual/TCI delivery of Propofol TIVA in above studies may be a limiting and a confounding factor in interpretating the actual difference induced by the 'gender' context. Whilst processed electroencephalogram (EEG) monitoring (Bispectral index [BIS], entropy, Narcotrend®) facilitates control of Propofol TIVA; it may still be imprecise due to subjective differences in understanding and execution of Propofol TIVA.
A recent advance in Propofol TIVA delivery is the development of automated anaesthesia delivery systems such as closed loop anaesthesia delivery system (CLADS). These systems administer Propofol actuated, titrated, and controlled by patients' processed electroencephalogram (EEG) response as generated by continuously monitored bispectral index (BIS) score. Current evidence suggests that automated Propofol TIVA delivery systems such as closed loop anaesthesia delivery system (CLADS) facilitate precision administration of Propofol than its TCI/manual counterparts.
Despite a plethora of evidence on effectiveness of Propofol TIVA, gender differences in Propofol PK and PD have not been evaluated while using automated systems of delivery. With the premise that widely researched and precise automated closed-loop anaesthesia delivery system (CLADS) has clear advantages (lower 'operator' dependence and inclusion of 'patient' factor) over manual/TCI mode; it is likely that Propofol TIVA administered by CLADS will lend greater objectivity in qualifying and quantifying the inter-gender differences in Propofol consumption and recovery from anaesthesia. The proposed observational study is planned to explore the gender differences in Propofol consumption and recovery from anaesthesia following CLADS controlled Propofol TIVA.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Delhi
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New Delhi, Delhi, India, 110060
- Sir Ganga Ram Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-60 years.
- ASA physical status I and II.
- Patients undergoing elective surgeries of minimum 1 hour duration.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Propofol consumption (mg/kg/h) during anaesthesia
Time Frame: From start of Propofol injection 10-hours intraoperatively]
|
Dose of Propofol required for induction and maintenance of anesthesia
|
From start of Propofol injection 10-hours intraoperatively]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative sedation
Time Frame: From end of anaesthesia till 24-hours postoperatively
|
Will be assessed using Modified Observer's assessment of alertness/sedation scale.
The scale has a maximum value of '5', which refers to a fully awake patient and a minimum value of '0' which refers to a deeply sedated patient.
|
From end of anaesthesia till 24-hours postoperatively
|
Time to loss of consciousness
Time Frame: From start of anesthesia till 5- minutes intraoperatively
|
The time taken from starting Propofol induction using closed-loop anaesthesia delivery system till loss of verbal response will be recorded
|
From start of anesthesia till 5- minutes intraoperatively
|
Time to induction of anaesthesia
Time Frame: From start of anesthesia till 5- minutes intraoperatively
|
The time taken from starting Propofol induction using closed-loop anaesthesia delivery system till a target BIS value of '50' is achieved
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From start of anesthesia till 5- minutes intraoperatively
|
Intra-operative heart rate (beats per minute)
Time Frame: From beginning of anesthesia till 10 hours intraoperatively
|
Comparison of intra-operative heart rate between the cohort groups will be done
|
From beginning of anesthesia till 10 hours intraoperatively
|
Intra-operative systolic , diastolic, and mean blood pressure (mmHg)
Time Frame: From beginning of anesthesia till 10 hours intraoperatively
|
Comparison of intra-operative blood pressure- systolic, diastolic, and mean blood pressure between the cohort groups will be done
|
From beginning of anesthesia till 10 hours intraoperatively
|
Anesthesia depth consistency
Time Frame: From beginning of anesthesia till 10 hours intraoperatively
|
It will be determined by the percentage of the anaesthesia time during which the BIS remained +/- 10 of the target BIS of 50
|
From beginning of anesthesia till 10 hours intraoperatively
|
Performance characteristic of Propofol delivery system
Time Frame: From beginning of anesthesia till 10 hours intraoperatively
|
It will be determined using the Varvel criteria parameter :median performance error (MDPE).
This parameter is calculated by the computer software which analyses the intraoperative BIS data.
This parameter have no unit of measurement.
Its just a abstract number
|
From beginning of anesthesia till 10 hours intraoperatively
|
Performance characteristic of Propofol delivery system
Time Frame: From beginning of anaesthesia till 10 hours intraoperatively
|
It will be determined using the Varvel criteria parameter: median absolute performance error (MDAPE).This parameter is calculated by the computer software which analyses the intraoperative BIS data.
This parameter have no unit of measurement.
Its just a abstract number.
|
From beginning of anaesthesia till 10 hours intraoperatively
|
Performance characteristic of Propofol delivery system
Time Frame: From beginning of anaesthesia till 10 hours intraoperatively
|
It will be determined using the Varvel criteria parameter: wobble.
This parameter is calculated by the computer software which analyses the intraoperative BIS data.
This parameter have no unit of measurement.
Its just a abstract number.
|
From beginning of anaesthesia till 10 hours intraoperatively
|
Performance characteristic of Propofol delivery system
Time Frame: From beginning of anaesthesia till 10 hours intraoperatively
|
It will be determined using the Varvel criteria parameter: global score.
It is calculated using the formula Median absolute performance error + wobble / percentage of the anesthesia time during which the BIS remained +/- 10 of the target BIS of 50.
This parameter have no unit of measurement.
Its just a abstract number.
|
From beginning of anaesthesia till 10 hours intraoperatively
|
Early recovery from anesthesia
Time Frame: From end of anaesthesia till 20-minutes postoperatively
|
Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted
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From end of anaesthesia till 20-minutes postoperatively
|
Early recovery from anesthesia
Time Frame: From end of anaesthesia till 20-minutes postoperatively
|
Time taken for tracheal extubation after discontinuation of anaesthesia will be noted
|
From end of anaesthesia till 20-minutes postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nitin Sethi, DNB, Sir Ganga Ram Hospital, New Delhi, INDIA
- Study Chair: Jayashree Sood, MD, FFRCA, PGDHHM, FICA, Sir Ganga Ram Hospital, New Delhi, INDIA
- Study Director: Amitabh Dutta, MD, PGDHR, Sir Ganga Ram Hospital, New Delhi, INDIA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/01/23/2217
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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