PNDNCT05297682
Effects of Repeated Intravenous Anesthesia With Propofol on the Postoperative Neurological Function of Patients Undergoing Hysteroscopic Surgery
An observational study of PND and Anesthesia, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Perioperative neurocognitive disorders(PND) is a common complication during the perioperative period, which affects the patient's rehabilitation and quality of life. Animal studies have found that repeated anesthesia and operation lead to neurological disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PND, Anesthesia
- What is being tested?
- anesthesia with propofol
- Type of treatment
- Medical device
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Jun 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The enrolled patients who were willing to give birth to undergo hysteroscopic surgery under intravenous general anesthesia were treated with the same protocol of propofol intravenous anesthesia, and the effects of different anesthesia times on the clinical endpoint were compared.
Who may be able to join
- Clinical diagnosis of intrauterine adhesions
- Need hysteroscopic surgery due to intrauterine adhesions
- Women of childbearing age who wish to have children
Who cannot join
- Those with contraindications to general anesthesia or those who had a history of anesthesia accident
- Those who are known or suspected to be allergic or contraindicated to propofol injection excipients
- Patients with acute upper respiratory tract infection, asthma attack, or acute severe laryngeal disease
- History of gastrointestinal disease: gastrointestinal retention, active bleeding, which may lead to reflux aspiration, etc.
- Complicated medical history of craniocerebral injury, intracranial hypertension, stroke, cerebrovascular accident
- Respiratory insufficiency, obstructive pulmonary disease
Show all 14Show fewer
- Uncontrolled hypertension, hypotension, and diabetes
- Severe arrhythmia, heart failure, unstable angina, myocardial infarction
- Severe liver dysfunction or severe renal insufficiency
- History of alcoholism or drug dependence
- Abuse or long-term use of narcotic, sedative, and analgesic drugs
- Those who have a history of mental illness
- Participated in any other clinical investigators within 1 month before screening
- Subjects who are considered by the investigator to have any other factors that are not suitable for participating in this research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital
Changsha, Hunan, 410013
Tunliang Li, M.D, 86-13787077468, 258629601@qq.com
About this study
Official title: Effects of Repeated Propofol Intravenous Anesthesia on the Postoperative Neurological Function of Patients Undergoing Hysteroscopic Surgery: A Prospective Cohort Study
Perioperative neurocognitive disorders(PND) is a common complication during the perioperative period, which affects the patient's rehabilitation and quality of life. Animal studies have found that repeated anesthesia and operation lead to neurological disorders. However, there is currently a lack of clinical studies on the effects of repeated anesthesia on patients' neurological function. With the full liberalization of China's three-child policy, the number of women in need of childbearing has increased, and infertile women who repeatedly undergo hysteroscopic surgery under intravenous anesthesia is increasing . Therefore, it is of great significance to investigate whether repeated and repeated general anesthesia and hysteroscopic surgery affect the patient's neurological function. The purpose of this study is to explore the effect of repeated propofol intravenous anesthesia on the neurological function of patients undergoing hysteroscopic surgery.
Read the detailed description
Central nervous system dysfunction is a common complication during the perioperative period, which affects the patient's rehabilitation and quality of life. Animal studies have found that repeated and multiple anesthesia operations can lead to neurological disorders. However, there is currently a lack of relevant clinical studies on the effects of multiple anesthesia operations on the neurological function of patients. With the full liberalization of China's family planning policy, the number of women in need of childbearing has increased, and the number of patients who repeatedly undergo hysteroscopic surgery under intravenous anesthesia due to infertility in the short term is increasing day by day. Therefore, it is of great significance to investigate whether repeated and repeated general anesthesia and hysteroscopic surgery affect the function of the patient's central nervous system.
Propofol and central nervous system dysfunction during perioperative period Perioperative neurocognitive disorders (PND) include neurocognitive disorders, sleep disorders, and anxiety and depression. The incidence rate is as high as 15%-78%, which affects the rehabilitation and quality of life of patients. A large number of studies have shown that a single anesthesia operation has a slight and short-term impact on the patient's neurological function. However, the impact of multiple anesthesia operations on the patient's neurological function is currently unclear.
Propofol was marketed in the UK in 1986, and was approved in the United States in 1989. It was approved for clinical use in my country in 1994, becoming a widely used clinical general anesthesia induction and maintenance drug. Animal experiments have found that a single exposure of propofol can cause transient neuronal apoptosis and defects in rats, while multiple exposures of propofol can lead to sustained neuronal apoptosis, neuronal defects, synaptic loss, and long-term Cognitive impairment. Repeated exposure to propofol in the neonatal period of rats can damage hippocampal synaptic plasticity and decline in cognitive function in adulthood. Repeated use of propofol can activate the NF-κB pathway and NLRP3 inflammasome, up-regulate the RAGE protein and other pathways, causing hippocampal inflammation and neuronal apoptosis, thereby impairing the cognitive function of elderly rats. The results of these animal studies suggest that repeated and multiple anesthesia operations can lead to neurological disorders. Clinical studies have reported that after a single propofol anesthesia in elderly patients undergoing laparoscopic surgery, 16.8%-18% of patients developed postoperative cognitive dysfunction 7 days after surgery; but whether repeated propofol anesthesia affects the patient's There is no research report on nerve function.
Intrauterine adhesions and transcervical resection of adhesion The infertility rate in China is currently as high as 12.5%-15%, and the number of patients exceeds 50 million, that is, 1 in every 8 couples has infertility problems. intrauterine adhesions (IUA) is a common gynecological uterine disease that seriously harms fertility and has poor treatment effects. It has become the main cause of secondary infertility in Chinese women. Transcervical resection of adhesion (TCRA) is the first choice for infertile women with fertility requirements to treat IUA. However, a large number of literature reports that the re-adhesion rate after TCRA is 30% in mild to moderate IUA, and as high as 62.5% in severe IUA, and the pregnancy success rate is only 22.5%-33.3%. Therefore, due to infertility, many women undergo repeated hysteroscopic surgery under general anesthesia in a short period of time, and some patients have undergone more than 10 anesthesia operations in just 2 years.
With the liberalization of China's plans to formulate policies, the number of patients with secondary infertility who have clinical needs continues to increase. Doctors have always paid more attention to the effect of increasing the uterine cavity of infertile patients, and the story of the neuronal function that may exist in such patients. Therefore, the change describes the clinical treatment plan for the actual infertility patients who have received general anesthesia and hysteroscopic surgery for many times. It is of great significance to social and economic development.
- Conditions
- PND, Anesthesia
- Being tested
- anesthesia with propofol
- Keywords
- PND
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia with propofolDevice
General anesthesia with propofol
| Study group | Role | What they receive |
|---|---|---|
| singal group | Patients receiving less than two anesthesia in a year Receives: Device: anesthesia with propofol | |
| repeat group | Patients who received two or more anesthesia in a year Receives: Device: anesthesia with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Measured by Montreal cognitive assessment(MoCA)score.The maximum score is 30 points. Lower scores mean worse cognitive function.
Measured: 2 months
Secondary outcomes (5)
Sleep assessment
Measured by The Pittsburgh Sleep Quality Index(PSQI )score.The PSQI global score has a range of 0-21 points.
Measured: 1day, 2months
Post-operative pain level
Measured by A numerical rating scale(NRS) score. Score range form 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 1day, 2 months
Postoperative nausea and/or vomiting (PONV)
Measured by postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation)
Measured: 1day
Anxiety level
Measured by Generalized Anxiety Disorder, (GAD7), GAD-7 total score for the seven items ranges from 0 to 21.0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: 1day, 2 months
Depression level
Measured by Patient Health Questionnaire-9 (PHQ-9).Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: 1day, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PNDStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Liao, M.D, Principal investigator, The Third Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297682
- Sponsor's protocol ID
- Liaoqinzff
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 10 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7.
PubMed 31881996Lee WL, Liu CH, Cheng M, Chang WH, Liu WM, Wang PH. Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision. Int J Mol Sci. 2021 May 13;22(10):5175. doi: 10.3390/ijms22105175.
PubMed 34068335Tasbihgou SR, Absalom AR. Postoperative neurocognitive disorders. Korean J Anesthesiol. 2021 Feb;74(1):15-22. doi: 10.4097/kja.20294. Epub 2020 Jul 6.
PubMed 32623846Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
PubMed 34116176Zhou Z, Zheng D, Wu H, Li R, Xu S, Kang Y, Cao Y, Chen X, Zhu Y, Xu S, Chen ZJ, Mol BW, Qiao J. Epidemiology of infertility in China: a population-based study. BJOG. 2018 Mar;125(4):432-441. doi: 10.1111/1471-0528.14966. Epub 2017 Dec 28.
PubMed 29030908
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Propofol Intravenous Anesthesia on the Postoperative Neurological Function of Patients Undergoing Hysteroscopic Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05297682
- Acronym / sponsor ID
- Liaoqinzff
- Conditions
- PND, Anesthesia
- Keywords
- PND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Mar 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.
Perioperative neurocognitive disorders(PND) is a common complication during the perioperative period, which affects the patient's rehabilitation and quality of life. Animal studies have found that repeated anesthesia and operation lead to neurological disorders. However, there is currently a lack of clinical studies on the effects of repeated anesthesia on patients' neurological function. With the full liberalization of China's three-child policy, the number of women in need of childbearing has increased, and infertile women who repeatedly undergo hysteroscopic surgery under intravenous anesthesia is increasing . Therefore, it is of great significance to investigate whether repeated and repeated general anesthesia and hysteroscopic surgery affect the patient's neurological function. The purpose of this study is to explore the effect of repeated propofol intravenous anesthesia on the neurological function of patients undergoing hysteroscopic surgery.
Detailed description
Central nervous system dysfunction is a common complication during the perioperative period, which affects the patient's rehabilitation and quality of life. Animal studies have found that repeated and multiple anesthesia operations can lead to neurological disorders. However, there is currently a lack of relevant clinical studies on the effects of multiple anesthesia operations on the neurological function of patients. With the full liberalization of China's family planning policy, the number of women in need of childbearing has increased, and the number of patients who repeatedly undergo hysteroscopic surgery under intravenous anesthesia due to infertility in the short term is increasing day by day. Therefore, it is of great significance to investigate whether repeated and repeated general anesthesia and hysteroscopic surgery affect the function of the patient's central nervous system.
Propofol and central nervous system dysfunction during perioperative period Perioperative neurocognitive disorders (PND) include neurocognitive disorders, sleep disorders, and anxiety and depression. The incidence rate is as high as 15%-78%, which affects the rehabilitation and quality of life of patients. A large number of studies have shown that a single anesthesia operation has a slight and short-term impact on the patient's neurological function. However, the impact of multiple anesthesia operations on the patient's neurological function is currently unclear.
Propofol was marketed in the UK in 1986, and was approved in the United States in 1989. It was approved for clinical use in my country in 1994, becoming a widely used clinical general anesthesia induction and maintenance drug. Animal experiments have found that a single exposure of propofol can cause transient neuronal apoptosis and defects in rats, while multiple exposures of propofol can lead to sustained neuronal apoptosis, neuronal defects, synaptic loss, and long-term Cognitive impairment. Repeated exposure to propofol in the neonatal period of rats can damage hippocampal synaptic plasticity and decline in cognitive function in adulthood. Repeated use of propofol can activate the NF-κB pathway and NLRP3 inflammasome, up-regulate the RAGE protein and other pathways, causing hippocampal inflammation and neuronal apoptosis, thereby impairing the cognitive function of elderly rats. The results of these animal studies suggest that repeated and multiple anesthesia operations can lead to neurological disorders. Clinical studies have reported that after a single propofol anesthesia in elderly patients undergoing laparoscopic surgery, 16.8%-18% of patients developed postoperative cognitive dysfunction 7 days after surgery; but whether repeated propofol anesthesia affects the patient's There is no research report on nerve function.
Intrauterine adhesions and transcervical resection of adhesion The infertility rate in China is currently as high as 12.5%-15%, and the number of patients exceeds 50 million, that is, 1 in every 8 couples has infertility problems. intrauterine adhesions (IUA) is a common gynecological uterine disease that seriously harms fertility and has poor treatment effects. It has become the main cause of secondary infertility in Chinese women. Transcervical resection of adhesion (TCRA) is the first choice for infertile women with fertility requirements to treat IUA. However, a large number of literature reports that the re-adhesion rate after TCRA is 30% in mild to moderate IUA, and as high as 62.5% in severe IUA, and the pregnancy success rate is only 22.5%-33.3%. Therefore, due to infertility, many women undergo repeated hysteroscopic surgery under general anesthesia in a short period of time, and some patients have undergone more than 10 anesthesia operations in just 2 years.
With the liberalization of China's plans to formulate policies, the number of patients with secondary infertility who have clinical needs continues to increase. Doctors have always paid more attention to the effect of increasing the uterine cavity of infertile patients, and the story of the neuronal function that may exist in such patients. Therefore, the change describes the clinical treatment plan for the actual infertility patients who have received general anesthesia and hysteroscopic surgery for many times. It is of great significance to social and economic development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| singal group | – | Device: anesthesia with propofolPatients receiving less than two anesthesia in a year |
| repeat group | – | Device: anesthesia with propofolPatients who received two or more anesthesia in a year |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The enrolled patients who were willing to give birth to undergo hysteroscopic surgery under intravenous general anesthesia were treated with the same protocol of propofol intravenous anesthesia, and the effects of different anesthesia times on the clinical endpoint were compared.
Key inclusion criteria (3 listed)
- Clinical diagnosis of intrauterine adhesions
- Need hysteroscopic surgery due to intrauterine adhesions
- Women of childbearing age who wish to have children
Key exclusion criteria (14 listed)
- Those with contraindications to general anesthesia or those who had a history of anesthesia accident
- Those who are known or suspected to be allergic or contraindicated to propofol injection excipients
- Patients with acute upper respiratory tract infection, asthma attack, or acute severe laryngeal disease
- History of gastrointestinal disease: gastrointestinal retention, active bleeding, which may lead to reflux aspiration, etc.
- Complicated medical history of craniocerebral injury, intracranial hypertension, stroke, cerebrovascular accident
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 |
|---|---|---|
| anesthesia with propofolGeneral anesthesia with propofol | Device | repeat group, singal group |
Primary outcome
Cognitive function
Time frame: 2 months
Measured by Montreal cognitive assessment(MoCA)score.The maximum score is 30 points. Lower scores mean worse cognitive function.
5 secondary outcomes
Sleep assessment
Time frame: 1day, 2months
Post-operative pain level
Time frame: 1day, 2 months
Postoperative nausea and/or vomiting (PONV)
Time frame: 1day
Anxiety level
Time frame: 1day, 2 months
Depression level
Time frame: 1day, 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 31881996Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7.
- Background: PubMed 34068335Lee WL, Liu CH, Cheng M, Chang WH, Liu WM, Wang PH. Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision. Int J Mol Sci. 2021 May 13;22(10):5175. doi: 10.3390/ijms22105175.
- Background: PubMed 32623846Tasbihgou SR, Absalom AR. Postoperative neurocognitive disorders. Korean J Anesthesiol. 2021 Feb;74(1):15-22. doi: 10.4097/kja.20294. Epub 2020 Jul 6.
- Background: PubMed 34116176Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
- Background: PubMed 29030908Zhou Z, Zheng D, Wu H, Li R, Xu S, Kang Y, Cao Y, Chen X, Zhu Y, Xu S, Chen ZJ, Mol BW, Qiao J. Epidemiology of infertility in China: a population-based study. BJOG. 2018 Mar;125(4):432-441. doi: 10.1111/1471-0528.14966. Epub 2017 Dec 28.
- 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.
Qin Liao, M.D principal investigator
The Third Xiangya Hospital, Central South University
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 PND and Anesthesia, run by The Third Xiangya Hospital of Central South 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 14 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 10 May 2022. 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 Qin Liao, M.D (86-0731- 88618269, zhanghaoliaoqin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 2 months). 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 NCT05297682, which also lists 5 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 10 May 2022.