Total Intravenous AnesthesiaNCT05401266
The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA
A study testing mild hypercapnia in people with Total Intravenous Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Intravenous Anesthesia
- What is being tested?
- mild hypercapnia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to 1 Jun 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 20-60 years, with American Society of Anesthesiology physical status 1 to 2, undergoing transurethral lithotripsy under TIVA with endotracheal intubation; voluntarily signed informed consent forms.
Who cannot join
- Patients with mental, pulmonary, cardiac, endocrine, neuromuscular, liver and nervous system diseases or a history of such diseases; Lung CT showed atelectasis, pulmonary infection and pleural effusion. Patients taking sedatives or other drugs that might interfere with the study; Alcohol or drug dependence; Patients who have had a history of general anesthesia within the past month; Patients with body mass index (BMI) of 30 kg/m2 or above; Patients who are expected to be under anesthesia for less than 30 minutes; Patients with difficult airways.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Lan Liu, Master, +86 13958033523, zrll@zju.edu.cn
Li Na Yu, PhD, +86 13958033387, zryulina@zju.edu.cn
About this study
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.
Read the detailed description
At present, there is no effective intervention method for the recovery of general anesthesia, and the elimination of anesthetic agents, especially from the brain is a decisive factor in the emergence from general anesthesia. Many studies have reported the effect of hypercapnia on recovery time from volatile anesthetics. Hypercapnia can increase cardiac output and cerebral blood flow, increasing the ability to remove volatile anesthetics from the brain and shortening the recovery time from anesthesia.
Propofol is becoming the most common intravenous agent used for induction as well as maintenance of total intravenous anesthesia (TIVA). Its rapid elimination from the blood and brain is expected to shorten the recovery time from TIVA. Only a few clinical studies have investigated the relationship between hypercapnia and emergence time with propofol anesthesia. But those studies may have been influenced by postoperative pain, so the recovery time cannot reflect propofol metabolism alone. Moreover, intraoperative hypercapnia may increase the need for intraoperative anesthetic agents by increasing the clearance of agents from the brain.
As a non-invasive method, Transcranial Doppler ultrasonography（TCD）can be used to monitor blood flow changes in different parts of cerebral arterial circle(Willis circle）, and its safety and effectiveness in perioperative related fields have been proved.
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.
- Conditions
- Total Intravenous Anesthesia
- Being tested
- mild hypercapnia
- Keywords
- hypercapnia, recovery time, total intravenous anesthesia
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild hypercapniaProcedure or surgery
Ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored
| Study group | Role | What they receive |
|---|---|---|
| normal blood carbonic acid level | No intervention | After propofol infusion was stopped, ventilation parameters were adjusted to maintain end-expiratory carbon dioxide (ETCO2) 35-40 mmHg until spontaneous respiration was restored. |
| mild hypercapnia | Experimental | After propofol infusion was stopped, ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored. Receives: Procedure: mild hypercapnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal extubation time
The time from propofol infusion stopped to Tracheal extubation
Measured: 1 year
Secondary outcomes (5)
Time of anesthesia
Time from anesthesia induction to cessation of propofol infusion
Measured: 1 year
Total infusion of propofol and remifentanil
Total infusion of propofol and remifentanil
Measured: 1 year
Spontaneous respiratory recovery time
The time from the beginning of cessation of propofol infusion to the time when the patient begins to cough or when the ETCO2 waveform changes
Measured: 1 year
Time of eyes or mouth opening
The time from the beginning of cessation of propofol infusion to the time when patients can open their eyes or mouth
Measured: 1 year
Changes in cerebral blood flow examined by transcranial Doppler (TCD)
Examine at the following four time points: before anesthesia induction; 10min after operation; After adjustment of ETCO2 is completed in post-anaesthesia care unit(PACU); 20 min after tracheal extubation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start5 Sep 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Intravenous AnesthesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Li Fang, PhD, Study director, Study Official Affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401266
- Sponsor's protocol ID
- 2022-0389
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA
- ClinicalTrials.gov ID
- NCT05401266
- Acronym / sponsor ID
- 2022-0389
- Conditions
- Total Intravenous Anesthesia
- Keywords
- hypercapnia, recovery time, total intravenous anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.
Detailed description
At present, there is no effective intervention method for the recovery of general anesthesia, and the elimination of anesthetic agents, especially from the brain is a decisive factor in the emergence from general anesthesia. Many studies have reported the effect of hypercapnia on recovery time from volatile anesthetics. Hypercapnia can increase cardiac output and cerebral blood flow, increasing the ability to remove volatile anesthetics from the brain and shortening the recovery time from anesthesia.
Propofol is becoming the most common intravenous agent used for induction as well as maintenance of total intravenous anesthesia (TIVA). Its rapid elimination from the blood and brain is expected to shorten the recovery time from TIVA. Only a few clinical studies have investigated the relationship between hypercapnia and emergence time with propofol anesthesia. But those studies may have been influenced by postoperative pain, so the recovery time cannot reflect propofol metabolism alone. Moreover, intraoperative hypercapnia may increase the need for intraoperative anesthetic agents by increasing the clearance of agents from the brain.
As a non-invasive method, Transcranial Doppler ultrasonography（TCD）can be used to monitor blood flow changes in different parts of cerebral arterial circle(Willis circle）, and its safety and effectiveness in perioperative related fields have been proved.
We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.
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 |
|---|---|---|
| normal blood carbonic acid level | No intervention | –After propofol infusion was stopped, ventilation parameters were adjusted to maintain end-expiratory carbon dioxide (ETCO2) 35-40 mmHg until spontaneous respiration was restored. |
| mild hypercapnia | Experimental | Procedure: mild hypercapniaAfter propofol infusion was stopped, ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 20-60 years, with American Society of Anesthesiology physical status 1 to 2, undergoing transurethral lithotripsy under TIVA with endotracheal intubation; voluntarily signed informed consent forms.
Key exclusion criteria (1 listed)
- Patients with mental, pulmonary, cardiac, endocrine, neuromuscular, liver and nervous system diseases or a history of such diseases; Lung CT showed atelectasis, pulmonary infection and pleural effusion. Patients taking sedatives or other drugs that might interfere with the study; Alcohol or drug dependence; Patients who have had a history of general anesthesia within the past month; Patients with body mass index (BMI) of 30 kg/m2 or above; Patients who are expected to be under anesthesia for less than 30 minutes; Patients with difficult airways.
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 |
|---|---|---|
| mild hypercapniaVentilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored | Procedure or surgery | mild hypercapnia |
Primary outcome
Tracheal extubation time
Time frame: 1 year
The time from propofol infusion stopped to Tracheal extubation
5 secondary outcomes
Time of anesthesia
Time frame: 1 year
Total infusion of propofol and remifentanil
Time frame: 1 year
Spontaneous respiratory recovery time
Time frame: 1 year
Time of eyes or mouth opening
Time frame: 1 year
Changes in cerebral blood flow examined by transcranial Doppler (TCD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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.
Li Li Fang, PhD study director
Study Official Affiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mild hypercapnia in people with Total Intravenous Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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 13 Feb 2023. 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?
Contact Lan Liu, Master (+86 13958033523, zrll@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheal extubation time (time frame: 1 year). 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 13 Feb 2023.