Post Induction HypotensionCTIHNCT06258967
Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients
A study testing ciprofol and propofol in people with Post Induction Hypotension and Elderly, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Geriatric patients undergoing general anesthesia face a significant challenge, with the induction phase contributing to 50% of hypotensive events. Titrated anesthesia, involving gradual drug administration, suits elderly induction. However, propofol in titrated anesthesia tends to induce hypotension. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Post Induction Hypotension, Elderly
- What is being tested?
- ciprofol and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years and age < 90 years.
- ASA (American Society of Anesthesiologists) physical status classification 1-3.
- Scheduled for elective general anesthesia surgery.
Who cannot join
- Participants already enrolled in other studies or those already assigned in this study .
- BMI (Body Mass Index) ≤ 18 or ≥ 30 kg/m2.
- Preoperative assessment indicating a challenging airway or a risk of aspiration, requiring a slow induction for intubation.
- Presence of severe liver or kidney disease (GFR ≤ 30 ml/min/1.73m2 or requiring renal replacement therapy; Child-Pugh class C for liver function).
- Patients with severe uncontrolled hypertension (preoperative SBP ≥ 180 mmHg or DBP ≥ 110 mmHg).
- Individuals with arrhythmias and severe valvular diseases, including high-degree atrioventricular block (Mobitz type II or third-degree block); symptomatic bradycardia; symptomatic ventricular arrhythmias; prolonged Q-T interval; supraventricular arrhythmias combined with an uncontrolled ventricular rate > 100 bpm (at rest); new-onset ventricular tachycardia; uncontrolled atrial fibrillation (ventricular rate ≥ 110 bpm); atrial flutter; severe aortic valve stenosis (mean pressure gradient > 40 mmHg; valve area < 1 cm2; symptomatic); severe mitral valve stenosis (progressive breathlessness during exertion; exertional syncope; heart failure).
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- Patients diagnosed with schizophrenia, epilepsy, Parkinson's disease, severe cognitive impairment, intellectual disability, hearing impairment.
- Individuals with a history of alcoholism or long-term use of sedatives and analgesics.
- Previous allergic reactions to medications used in this study.
- Individuals already under vasoconstrictor treatment before anesthesia induction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Hong Bai, professor, +8613480250519, bhong@mail.sysu.edu.cn
About this study
Official title: A Prospective Randomized Controlled Trail of Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients Under General Anesthesia
Geriatric patients undergoing general anesthesia face a significant challenge, with the induction phase contributing to 50% of hypotensive events.
Titrated anesthesia, involving gradual drug administration, suits elderly induction. However, propofol in titrated anesthesia tends to induce hypotension. In contrast, Ciprofol (HSK3486), a novel anesthetic, reduces hypotension during induction. This study compares hypotension incidences during induction and post-induction phases, agitation rates during recovery, perioperative awareness, postoperative delirium, and parameters in elderly patients induced with Ciprofol versus propofol through titrated anesthesia. The goal is to clarify a medically optimized anesthesia protocol for elderly patients during titrated anesthesia induction in general anesthesia.
Read the detailed description
As the global population ages, there is a growing demand for surgical interventions among the elderly. However, this demographic is concurrently faced with an increased susceptibility to postoperative complications. Notably, the geriatric population undergoing general anesthesia exhibits a higher incidence of hypotension, intricately linked with a spectrum of postoperative issues. The induction phase of general anesthesia, constituting 50% of hypotensive events, presents a significant challenge in mitigating hypotension.
Titrated anesthesia, characterized by gradual and individualized drug administration, emerges as a suitable approach for the induction of general anesthesia in the elderly. Nevertheless, the administration of propofol through titrated anesthesia maintains an observable tendency to induce hypotension.
In contrast, Ciprofol (HSK3486), a novel anesthetic agent, demonstrates a reduced propensity for precipitating hypotension during the induction of anesthesia. This investigative study aims to meticulously examine and compare the incidences of hypotension during both the induction and post-induction phases. Furthermore, it endeavors to delineate differences in the rates of agitation during the recovery phase, perioperative awareness, postoperative delirium, and other relevant parameters among elderly patients induced with ciprofol versus propofol via titrated anesthesia.
A sample size of 80 patients in each group will be selected by a prior power analysis on the basis of the following assumptions: (1) the rate of hypotension in group Propofol was 57%; and 30%in group Cipropfol (2)α=0.05, (4) power 90% and .(5) missed follow-up rate 12%.
After obtaining informed consent, all participants will be randomized to one of the trial groups using a stratified method. A 20G catheter will be inserted into the radial artery before anesthesia induction. Vital signs will be recorded from 3 minutes before general induction until 15 minutes after tracheal intubation. Participants in Group P will undergo induction with propofol, starting at a rate of 15mg/kg/h until loss of consciousness, followed by an adjustment to a slower infusion rate. In contrast, Group C will receive ciprofol at a rate of 3mg/kg/h. Following the intervention period, all participants will receive sevoflurane and remifentanil until the conclusion of the surgery. Both groups will be followed up for 7 days postoperatively to assess perioperative awareness, postoperative delirium, quality of recovery, and postoperative complications.
- Conditions
- Post Induction Hypotension, Elderly
- Being tested
- ciprofol, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
Patients receive ciprofol as general anesthesia induction drug, using the titrated anesthesia method.
propofolDrug
Patients receive propofol as general anesthesia induction drug, using the titrated anesthesia method.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol is administered at a rate of 15mg/kg*h for patient induction. After 60 seconds, a sedation assessment is initiated until the patient loses consciousness.Then adjust the propofol dose to 5mg/kg/h and make further dose adjustments based on the patient's response and BIS value, with increments or decrements ranging from 1mg/kg/h, within a total range of 3-8mg/kg/h. Receives: Drug: propofol |
| Ciprofol | Experimental | Cprofol is administered at a rate of 3mg/kg*h for patient induction. After 60 seconds, a sedation assessment is initiated until the patient loses consciousness.Then adjust the propofol dose to 1mg/kg/h and make further dose adjustments based on the patient's response, with increments or decrements ranging from 0.2mg/kg/h, within a total range of 0.6-1.6mg/kg/h. Receives: Drug: ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the incidence of hypotension occurring 15 minutes after successful intubation between the two groups.
Hypotension is defined as a mean arterial pressure (MAP) of 65 mmHg or lower. The occurrence of hypotension in each group will be documented.
Measured: From successful tracheal intubation to 15 minutes later.
Secondary outcomes (16)
Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) < 65 mmHg.
This outcome will be caculated as: (65-MAP)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
Time-weighted area under the curve of blood pressure during the induction and post-induction phases of anesthesia with a mean arterial pressure (MAP) ≤ 70% of the baseline value.
This outcome will be caculated as: (70%*MAPbaseline -MAP)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
Time-weighted area between the curve of blood pressure and the target MAP(110mmHg,120mmHg) during the post-induction period
This outcome will be caculated as: (MAP-110)(mmHg)*Time(min) and (MAP-110)(mmHg)*Time(min) and (MAP-120)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
The dose of norepinephrine used during the induction and post-induction periods.
Norepinephrine dosage in each group will be recorded.
Measured: From the administration of general anesthesia with an induction drug to 15 minutes after tracheal intubation has been completed.
Total time for patient loss of consciousness
Time from anesthetic drug adminisered to patient's OAA/S score reached 1
Measured: During anesthesia induction
Trends in CO( cardiac output)
A divice will analyse the invasive BP wave ,caculated patient's CO, and will be recorded.
Measured: from 1min before aneshesia induction until 20minuts after study durg administered.
Incidence of agitation during the post-anesthesia recovery period and early postoperative delirium .
Patients will be astimated using the Richmond Agitation Sedation Scale (RASS, the score between -5~+4) and Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).The rate of agitation of each group will be recorded.
Measured: 30min and 1hour after patients arrived the PACU
Incidence of perioperative awareness
The rate of awareness in each group will be recorded.
Measured: 1,2,3 days postoperatively
Incidence of postoperative nausea and vomiting
Rate of participants with nausea and vomiting
Measured: postoperative 1,2,3days
Incidence of Postoperative delirium
The postoperative delirium will be screened using the 3-Minute Diagnostic confusion assessment method (3D-CAM).If patients is in the ICU ,then will be screened with CAM-ICU method.The rate of deilirium in each group will be recorded.
Measured: 1,2,3days postoperatively
Incidence of complications within 7 days postoperatively.
All complications were evaluated according to the Clavian-Dindo Classification of Surgical Complications (CD). The CD scoring system is divided into five levels, with the more severe the complication, the higher the score.The occurrence of Clavien-Dindo grade ≥2 in each group will be recorded.
Measured: 7 days postoperatively.
The difference of Postoperative Quality of Recovery-15 (QoR-15) score.
The Quality of Recovery-15 (QoR-15) score,which has a max score of 150,and minimum score of 0, and a higher score means a bettery recovery. The score of each group will be recorded.
Measured: 1,2,3 days postoperatively
Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) <55 mmHg.
This outcome will be caculated as: (55-MAP)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) ≥140 mmHg.
This outcome will be caculated as: (MAP-140)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) >110 mmHg.
This outcome will be caculated as: (MAP-110)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) >120 mmHg.
This outcome will be caculated as: (MAP-120)(mmHg)*Time(min)
Measured: From successful tracheal intubation to 15 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start20 Feb 2024
- Primary completion24 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Induction HypotensionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258967
- Sponsor's protocol ID
- 2023ZSLYEC-636
- Acronym
- CTIH
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 15 Jul 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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trail of Ciprofol Titrated Induction in Reducing Post-induction Hypotension in Geriatric Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06258967
- Acronym / sponsor ID
- CTIH / 2023ZSLYEC-636
- Conditions
- Post Induction Hypotension, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Feb 2024 (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.
Geriatric patients undergoing general anesthesia face a significant challenge, with the induction phase contributing to 50% of hypotensive events.
Titrated anesthesia, involving gradual drug administration, suits elderly induction. However, propofol in titrated anesthesia tends to induce hypotension. In contrast, Ciprofol (HSK3486), a novel anesthetic, reduces hypotension during induction. This study compares hypotension incidences during induction and post-induction phases, agitation rates during recovery, perioperative awareness, postoperative delirium, and parameters in elderly patients induced with Ciprofol versus propofol through titrated anesthesia. The goal is to clarify a medically optimized anesthesia protocol for elderly patients during titrated anesthesia induction in general anesthesia.
Detailed description
As the global population ages, there is a growing demand for surgical interventions among the elderly. However, this demographic is concurrently faced with an increased susceptibility to postoperative complications. Notably, the geriatric population undergoing general anesthesia exhibits a higher incidence of hypotension, intricately linked with a spectrum of postoperative issues. The induction phase of general anesthesia, constituting 50% of hypotensive events, presents a significant challenge in mitigating hypotension.
Titrated anesthesia, characterized by gradual and individualized drug administration, emerges as a suitable approach for the induction of general anesthesia in the elderly. Nevertheless, the administration of propofol through titrated anesthesia maintains an observable tendency to induce hypotension.
In contrast, Ciprofol (HSK3486), a novel anesthetic agent, demonstrates a reduced propensity for precipitating hypotension during the induction of anesthesia. This investigative study aims to meticulously examine and compare the incidences of hypotension during both the induction and post-induction phases. Furthermore, it endeavors to delineate differences in the rates of agitation during the recovery phase, perioperative awareness, postoperative delirium, and other relevant parameters among elderly patients induced with ciprofol versus propofol via titrated anesthesia.
A sample size of 80 patients in each group will be selected by a prior power analysis on the basis of the following assumptions: (1) the rate of hypotension in group Propofol was 57%; and 30%in group Cipropfol (2)α=0.05, (4) power 90% and .(5) missed follow-up rate 12%.
After obtaining informed consent, all participants will be randomized to one of the trial groups using a stratified method. A 20G catheter will be inserted into the radial artery before anesthesia induction. Vital signs will be recorded from 3 minutes before general induction until 15 minutes after tracheal intubation. Participants in Group P will undergo induction with propofol, starting at a rate of 15mg/kg/h until loss of consciousness, followed by an adjustment to a slower infusion rate. In contrast, Group C will receive ciprofol at a rate of 3mg/kg/h. Following the intervention period, all participants will receive sevoflurane and remifentanil until the conclusion of the surgery. Both groups will be followed up for 7 days postoperatively to assess perioperative awareness, postoperative delirium, quality of recovery, and postoperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolPropofol is administered at a rate of 15mg/kg*h for patient induction. After 60 seconds, a sedation assessment is initiated until the patient loses consciousness.Then adjust the propofol dose to 5mg/kg/h and make further dose adjustments based on the patient's response and BIS value, with increments or decrements ranging from 1mg/kg/h, within a total range of 3-8mg/kg/h. |
| Ciprofol | Experimental | Drug: ciprofolCprofol is administered at a rate of 3mg/kg*h for patient induction. After 60 seconds, a sedation assessment is initiated until the patient loses consciousness.Then adjust the propofol dose to 1mg/kg/h and make further dose adjustments based on the patient's response, with increments or decrements ranging from 0.2mg/kg/h, within a total range of 0.6-1.6mg/kg/h. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years and age < 90 years.
- ASA (American Society of Anesthesiologists) physical status classification 1-3.
- Scheduled for elective general anesthesia surgery.
Key exclusion criteria (10 listed)
- Participants already enrolled in other studies or those already assigned in this study .
- BMI (Body Mass Index) ≤ 18 or ≥ 30 kg/m2.
- Preoperative assessment indicating a challenging airway or a risk of aspiration, requiring a slow induction for intubation.
- Presence of severe liver or kidney disease (GFR ≤ 30 ml/min/1.73m2 or requiring renal replacement therapy; Child-Pugh class C for liver function).
- Patients with severe uncontrolled hypertension (preoperative SBP ≥ 180 mmHg or DBP ≥ 110 mmHg).
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 |
|---|---|---|
| ciprofolPatients receive ciprofol as general anesthesia induction drug, using the titrated anesthesia method. | Drug | Ciprofol |
| propofolPatients receive propofol as general anesthesia induction drug, using the titrated anesthesia method. | Drug | Propofol |
Primary outcome
The difference in the incidence of hypotension occurring 15 minutes after successful intubation between the two groups.
Time frame: From successful tracheal intubation to 15 minutes later.
Hypotension is defined as a mean arterial pressure (MAP) of 65 mmHg or lower. The occurrence of hypotension in each group will be documented.
16 secondary outcomes
Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) < 65 mmHg.
Time frame: From successful tracheal intubation to 15 minutes later.
Time-weighted area under the curve of blood pressure during the induction and post-induction phases of anesthesia with a mean arterial pressure (MAP) ≤ 70% of the baseline value.
Time frame: From successful tracheal intubation to 15 minutes later.
Time-weighted area between the curve of blood pressure and the target MAP(110mmHg,120mmHg) during the post-induction period
Time frame: From successful tracheal intubation to 15 minutes later.
The dose of norepinephrine used during the induction and post-induction periods.
Time frame: From the administration of general anesthesia with an induction drug to 15 minutes after tracheal intubation has been completed.
Total time for patient loss of consciousness
Time frame: During anesthesia induction
Trends in CO( cardiac output)
Time frame: from 1min before aneshesia induction until 20minuts after study durg administered.
Incidence of agitation during the post-anesthesia recovery period and early postoperative delirium .
Time frame: 30min and 1hour after patients arrived the PACU
Incidence of perioperative awareness
Time frame: 1,2,3 days postoperatively
Incidence of postoperative nausea and vomiting
Time frame: postoperative 1,2,3days
Incidence of Postoperative delirium
Time frame: 1,2,3days postoperatively
Incidence of complications within 7 days postoperatively.
Time frame: 7 days postoperatively.
The difference of Postoperative Quality of Recovery-15 (QoR-15) score.
Time frame: 1,2,3 days postoperatively
Time-weighted area under the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) <55 mmHg.
Time frame: From successful tracheal intubation to 15 minutes later.
Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) ≥140 mmHg.
Time frame: From successful tracheal intubation to 15 minutes later.
Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) >110 mmHg.
Time frame: From successful tracheal intubation to 15 minutes later.
Time-weighted area upon the curve of blood pressure during the post-induction phases of anesthesia with a mean arterial pressure (MAP) >120 mmHg.
Time frame: From successful tracheal intubation to 15 minutes later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofol and propofol in people with Post Induction Hypotension and Elderly, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 15 Jul 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the incidence of hypotension occurring 15 minutes after successful intubation between the two groups. (time frame: From successful tracheal intubation to 15 minutes later.). 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 15 Jul 2024.