Propofol Adverse ReactionPhase 4propofolNCT06862349
Propofol Induction Based on Lean Body Weight on the Depth of Anesthesia
A Phase 4 study testing Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight and Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist. in people with Propofol Adverse Reaction, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Propofol has significant hemodynamic side effects. It is a lipophilic agent and is generally used at a dose of 2-2.5 mg/kg for induction. In patients with a body mass index (BMI) greater than 25, it can lead to serious complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Propofol Adverse Reaction
- What is being tested?
- Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight and Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 27 Feb 2025
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A total of 120 patients of both genders,
- Aged 18-65 years,
- BMI >25
- Scheduled for elective surgery under general anesthesia in the urology operating room
Who cannot join
- Patients under 18 years of age or over 65 years old
- Patients unable to read, understand, or sign the consent form
- Hemodynamically unstable patients
- Patients with contraindications to anesthetic drugs
- Patients who do not wish to participate in the study
- Patients deemed unsuitable by the researcher
Show all 16Show fewer
- Patients with advanced dementia or behavioral disorders
- Patients using psychiatric medications or abusing drugs
- Patients requiring awake intubation
- Emergency surgical procedures
- Patients with more than a 5% weight change between the time of the CT scan --and the surgery day
- A time gap of more than 2 months between the CT scan and the surgery day
- The criteria for discontinuing the study are as follows:
- Patients who develop anaphylaxis
- Airway failure
- Patients who develop unexpected complications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800
About this study
Official title: The Effect of Propofol Induction Using Total Body Weight and Lean Body Weight Obtained by Tomographic Measurements; on the Depth of Anesthesia in Patients Receiving General Anesthesia
Propofol has significant hemodynamic side effects. It is a lipophilic agent and is generally used at a dose of 2-2.5 mg/kg for induction. In patients with a body mass index (BMI) greater than 25, it can lead to serious complications. This patient group often has comorbidities such as hypertension, coronary artery disease, left ventricular hypertrophy, stroke, and obstructive sleep apnea.
Hemodynamic profile changes are influenced by both the rate of propofol administration and the total dose. Therefore, it is necessary to investigate the appropriate dose and infusion rate of propofol during anesthesia induction.
Read more
The primary aim of this study is to compare the effects of propofol induction doses, determined based on total body weight and lean body weight (calculated using tomography), on anesthesia depth using BIS and SedLine monitoring in patients with BMI >25.
The secondary aim of the study is to compare propofol induction doses calculated using two different methods in terms of:
- Mean arterial pressure (MAP),
- Frequency of hypotension (MAP <65),
- Frequency of Trendelenburg position or vasopressor requirement and their response,
- Tachycardia (heart rate >100 bpm),
- Frequency of hypertension (SBP >140).
Additionally, the sensitivity and delay rates of BIS and SedLine monitoring in determining anesthesia depth were compared.
A total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl.
- Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight.
- Group L received propofol at a dose of 2-2.5 mg/kg based on lean body weight, which was calculated from CT imaging by a radiologist.
- Propofol was administered at a rate of 100 mg/min.
The laryngeal mask will be placed once an adequate depth of anesthesia is achieved.
All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison.
- Conditions
- Propofol Adverse Reaction
- Being tested
- Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight, Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.
- Keywords
- lean body mass, propofol adverse reaction, general anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group T received propofol at a dose of 2-2.5 mg/kg based on total body weightDrug
A total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight. Propofol was administered at a rate of 100 mg/min. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison.
Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.Drug
A total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist. Propofol was administered at a rate of 100 mg/min. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Group T | Active comparator | All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. Receives: Drug: Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight |
| Group L | Active comparator | All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group T received propofol at a dose of 2-2.5 mg/kg based on lean body weight. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. Receives: Drug: Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
anaesthesia debt
Anesthesia depth was assessed using BIS and SedLine monitoring before and after induction and recorded every 2 minutes.
Measured: 30 minute
Secondary outcomes (4)
mean arterial pressure
Mean arterial pressure was measured before and after induction and recorded every 2 minutes.
Measured: 30 minute
trendelenburg
The need for Trendelenburg position due to hypotension before and after induction was recorded every 2 minutes.
Measured: 30 minute
vasopressor
The need for vasopressor due to hypotension before and after induction was recorded every 2 minutes.
Measured: 30 minute
heart
Heart rate was recorded every 2 minutes before and after induction, allowing the rate of tachycardia development to be monitored as a study outcome.
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jan 2025
- Primary completion20 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Propofol Adverse ReactionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862349
- Sponsor's protocol ID
- propofol induction
- Acronym
- propofol
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt GN, Bischoff P, Standl T, Lankenau G, Hilbert M, Schulte Am Esch J. Comparative evaluation of Narcotrend, Bispectral Index, and classical electroencephalographic variables during induction, maintenance, and emergence of a propofol/remifentanil anesthesia. Anesth Analg. 2004 May;98(5):1346-53, table of contents. doi: 10.1213/01.ane.0000111209.44119.30.
PubMed 15105213Gurses E, Sungurtekin H, Tomatir E, Dogan H. Assessing propofol induction of anesthesia dose using bispectral index analysis. Anesth Analg. 2004 Jan;98(1):128-131. doi: 10.1213/01.ANE.0000090314.43496.1D.
PubMed 14693603Pilge S, Zanner R, Schneider G, Blum J, Kreuzer M, Kochs EF. Time delay of index calculation: analysis of cerebral state, bispectral, and narcotrend indices. Anesthesiology. 2006 Mar;104(3):488-94. doi: 10.1097/00000542-200603000-00016.
PubMed 16508396Rusch D, Arndt C, Eberhart L, Tappert S, Nageldick D, Wulf H. Bispectral index to guide induction of anesthesia: a randomized controlled study. BMC Anesthesiol. 2018 Jun 15;18(1):66. doi: 10.1186/s12871-018-0522-8.
PubMed 29902969
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Induction Using Total Body Weight and Lean Body Weight Obtained by Tomographic Measurements; on the Depth of Anesthesia in Patients Receiving General Anesthesia
- ClinicalTrials.gov ID
- NCT06862349
- Acronym / sponsor ID
- propofol / propofol induction
- Conditions
- Propofol Adverse Reaction
- Keywords
- lean body mass, propofol adverse reaction, general anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 6 Mar 2025 (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.
Propofol has significant hemodynamic side effects. It is a lipophilic agent and is generally used at a dose of 2-2.5 mg/kg for induction. In patients with a body mass index (BMI) greater than 25, it can lead to serious complications. This patient group often has comorbidities such as hypertension, coronary artery disease, left ventricular hypertrophy, stroke, and obstructive sleep apnea.
Hemodynamic profile changes are influenced by both the rate of propofol administration and the total dose. Therefore, it is necessary to investigate the appropriate dose and infusion rate of propofol during anesthesia induction.
The primary aim of this study is to compare the effects of propofol induction doses, determined based on total body weight and lean body weight (calculated using tomography), on anesthesia depth using BIS and SedLine monitoring in patients with BMI >25.
The secondary aim of the study is to compare propofol induction doses calculated using two different methods in terms of:
- Mean arterial pressure (MAP),
- Frequency of hypotension (MAP <65),
- Frequency of Trendelenburg position or vasopressor requirement and their response,
- Tachycardia (heart rate >100 bpm),
- Frequency of hypertension (SBP >140).
Additionally, the sensitivity and delay rates of BIS and SedLine monitoring in determining anesthesia depth were compared.
A total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl.
- Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight.
- Group L received propofol at a dose of 2-2.5 mg/kg based on lean body weight, which was calculated from CT imaging by a radiologist.
- Propofol was administered at a rate of 100 mg/min.
The laryngeal mask will be placed once an adequate depth of anesthesia is achieved.
All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | Active comparator | Drug: Group T received propofol at a dose of 2-2.5 mg/kg based on total body weightAll patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. |
| Group L | Active comparator | Drug: Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group T received propofol at a dose of 2-2.5 mg/kg based on lean body weight. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A total of 120 patients of both genders,
- Aged 18-65 years,
- BMI >25
- Scheduled for elective surgery under general anesthesia in the urology operating room
Key exclusion criteria (16 listed)
- Patients under 18 years of age or over 65 years old
- Patients unable to read, understand, or sign the consent form
- Hemodynamically unstable patients
- Patients with contraindications to anesthetic drugs
- Patients who do not wish to participate in the study
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 |
|---|---|---|
| Group T received propofol at a dose of 2-2.5 mg/kg based on total body weightA total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight. Propofol was administered at a rate of 100 mg/min. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison. | Drug | Group T |
| Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.A total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl. Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist. Propofol was administered at a rate of 100 mg/min. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved. All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison. | Drug | Group L |
Primary outcome
anaesthesia debt
Time frame: 30 minute
Anesthesia depth was assessed using BIS and SedLine monitoring before and after induction and recorded every 2 minutes.
4 secondary outcomes
mean arterial pressure
Time frame: 30 minute
trendelenburg
Time frame: 30 minute
vasopressor
Time frame: 30 minute
heart
Time frame: 30 minute
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 6 Mar 2025.
- Results publication: PubMed 15105213Schmidt GN, Bischoff P, Standl T, Lankenau G, Hilbert M, Schulte Am Esch J. Comparative evaluation of Narcotrend, Bispectral Index, and classical electroencephalographic variables during induction, maintenance, and emergence of a propofol/remifentanil anesthesia. Anesth Analg. 2004 May;98(5):1346-53, table of contents. doi: 10.1213/01.ane.0000111209.44119.30.
- Results publication: PubMed 14693603Gurses E, Sungurtekin H, Tomatir E, Dogan H. Assessing propofol induction of anesthesia dose using bispectral index analysis. Anesth Analg. 2004 Jan;98(1):128-131. doi: 10.1213/01.ANE.0000090314.43496.1D.
- Results publication: PubMed 16508396Pilge S, Zanner R, Schneider G, Blum J, Kreuzer M, Kochs EF. Time delay of index calculation: analysis of cerebral state, bispectral, and narcotrend indices. Anesthesiology. 2006 Mar;104(3):488-94. doi: 10.1097/00000542-200603000-00016.
- Results publication: PubMed 29902969Rusch D, Arndt C, Eberhart L, Tappert S, Nageldick D, Wulf H. Bispectral index to guide induction of anesthesia: a randomized controlled study. BMC Anesthesiol. 2018 Jun 15;18(1):66. doi: 10.1186/s12871-018-0522-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight and Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist. in people with Propofol Adverse Reaction, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 4 inclusion and 16 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 6 Mar 2025. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
anaesthesia debt (time frame: 30 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862349, which also lists 4 linked publications.
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 6 Mar 2025.