AnesthesiaNCT05725135
Effect of Gender on Propofol Requirement
An observational study of Anesthesia, run by Sir Ganga Ram Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2023to 19 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing elective surgery requiring general anesthesia
Who may be able to join
- Age 18-60 years.
- ASA physical status I and II.
- Patients undergoing elective surgeries of minimum 1 hour duration.
Who cannot join
- 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
Show all 10Show fewer
- History of recent intake of sedative medication or anti-psychotic medication
- Drug dependence/substance abuse
- Requirement of postoperative ventilation
- Refusal to informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Official title: Gender Differences in Propofol Requirements During Total Intravenous Anaesthesia Administered by Closed-loop Anaesthesia Delivery System: An Observational Study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Propofol
- Keywords
- propofol, male, female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Propofol consumption (mg/kg/h) during anaesthesia
Dose of Propofol required for induction and maintenance of anesthesia
Measured: From start of Propofol injection 10-hours intraoperatively]
Secondary outcomes (12)
Time to loss of consciousness
The time taken from starting Propofol induction using closed-loop anaesthesia delivery system till loss of verbal response will be recorded
Measured: From start of anesthesia till 5- minutes intraoperatively
Time to induction of anaesthesia
The time taken from starting Propofol induction using closed-loop anaesthesia delivery system till a target BIS value of '50' is achieved
Measured: From start of anesthesia till 5- minutes intraoperatively
Intra-operative heart rate (beats per minute)
Comparison of intra-operative heart rate between the cohort groups will be done
Measured: From beginning of anesthesia till 10 hours intraoperatively
Intra-operative systolic , diastolic, and mean blood pressure (mmHg)
Comparison of intra-operative blood pressure- systolic, diastolic, and mean blood pressure between the cohort groups will be done
Measured: From beginning of anesthesia till 10 hours intraoperatively
Anesthesia 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
Measured: From beginning of anesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
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
Measured: From beginning of anesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
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.
Measured: From beginning of anaesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
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.
Measured: From beginning of anaesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
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.
Measured: From beginning of anaesthesia till 10 hours intraoperatively
Early recovery from anesthesia
Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted
Measured: From end of anaesthesia till 20-minutes postoperatively
Early recovery from anesthesia
Time taken for tracheal extubation after discontinuation of anaesthesia will be noted
Measured: From end of anaesthesia till 20-minutes postoperatively
Postoperative sedation
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.
Measured: From end of anaesthesia till 24-hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Feb 2023
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Sethi, DNB, Sir Ganga Ram Hospital
- Investigators
- Nitin Sethi, DNB, Principal investigator, Sir Ganga Ram Hospital, New Delhi, INDIAAmitabh Dutta, MD, PGDHR, Study director, Sir Ganga Ram Hospital, New Delhi, INDIAJayashree Sood, MD, FFRCA, PGDHHM, FICA, Study chair, Sir Ganga Ram Hospital, New Delhi, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725135
- Sponsor's protocol ID
- EC/01/23/2217
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Propofol Requirements During Total Intravenous Anaesthesia Administered by Closed-loop Anaesthesia Delivery System: An Observational Study
- ClinicalTrials.gov ID
- NCT05725135
- Acronym / sponsor ID
- EC/01/23/2217
- Conditions
- Anesthesia
- Keywords
- propofol, male, female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | – | Drug: PropofolPropofol 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. |
| Females | – | Drug: PropofolPropofol 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing elective surgery requiring general anesthesia
Key inclusion criteria (3 listed)
- Age 18-60 years.
- ASA physical status I and II.
- Patients undergoing elective surgeries of minimum 1 hour duration.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol total intravenous anesthesia (TIVA) will be used for induction and maintenance of anesthesia. Propofol will be delivered using automated closed-loop anesthesia delivery system. | Drug | Females, Males |
Primary outcome
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
12 secondary outcomes
Time to loss of consciousness
Time frame: From start of anesthesia till 5- minutes intraoperatively
Time to induction of anaesthesia
Time frame: 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
Intra-operative systolic , diastolic, and mean blood pressure (mmHg)
Time frame: From beginning of anesthesia till 10 hours intraoperatively
Anesthesia depth consistency
Time frame: From beginning of anesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
Time frame: From beginning of anesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
Time frame: From beginning of anaesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
Time frame: From beginning of anaesthesia till 10 hours intraoperatively
Performance characteristic of Propofol delivery system
Time frame: From beginning of anaesthesia till 10 hours intraoperatively
Early recovery from anesthesia
Time frame: From end of anaesthesia till 20-minutes postoperatively
Early recovery from anesthesia
Time frame: From end of anaesthesia till 20-minutes postoperatively
Postoperative sedation
Time frame: From end of anaesthesia till 24-hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Sethi, DNB principal investigator
Sir Ganga Ram Hospital, New Delhi, INDIA
Amitabh Dutta, MD, PGDHR study director
Sir Ganga Ram Hospital, New Delhi, INDIA
Jayashree Sood, MD, FFRCA, PGDHHM, FICA study chair
Sir Ganga Ram Hospital, New Delhi, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Sir Ganga Ram Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Propofol consumption (mg/kg/h) during anaesthesia (time frame: From start of Propofol injection 10-hours intraoperatively]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.