Effects of Repeated Intravenous Anesthesia With Propofol on the Postoperative Neurological Function of Patients Undergoing Hysteroscopic Surgery

Anesthesia Clinical Trial

Official title:

Effects of Repeated Propofol Intravenous Anesthesia on the Postoperative Neurological Function of Patients Undergoing Hysteroscopic Surgery: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297682
• Other study ID #: Liaoqinzff
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2022
• Source: The Third Xiangya Hospital of Central South University
• Contact: Qin Liao, M.D
• Phone: 86-0731- 88618269
• Email: zhanghaoliaoqin[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: June 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of intrauterine adhesions

• Need hysteroscopic surgery due to intrauterine adhesions

• Women of childbearing age who wish to have children

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Anesthesia
• PND

Intervention

Device:
• anesthesia with propofol
General anesthesia with propofol

Locations

Country	Name	City	State
China	The Third Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View Citation

Lee 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). pii: 5175. doi: 10.3390/ijms22105175. Review. — View Citation

Tasbihgou SR, Absalom AR. Postoperative neurocognitive disorders. Korean J Anesthesiol. 2021 Feb;74(1):15-22. doi: 10.4097/kja.20294. Epub 2020 Jul 6. — View Citation

Teng 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. — View Citation

Zhou 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	Measured by Montreal cognitive assessment(MoCA)score.The maximum score is 30 points. Lower scores mean worse cognitive function.	2 months
Secondary	Sleep assessment	Measured by The Pittsburgh Sleep Quality Index(PSQI )score.The PSQI global score has a range of 0-21 points.	1day, 2months
Secondary	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.	1day, 2 months
Secondary	Postoperative nausea and/or vomiting (PONV)	Measured by postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation)	1day
Secondary	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	1day, 2 months
Secondary	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.	1day, 2 months