Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety

Sleep Disturbance Clinical Trial

Official title:

Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284668
• Other study ID #: GWang027
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: July 10, 2024

Study information

• Verified date: March 2024
• Source: Tianjin Medical University General Hospital
• Contact: Guolin Wang
• Phone: +8615822855556
• Email: wangguolinghad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval

Description:

Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery. Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance is worth exploring.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 10, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 18-45 years old;

2. American society of Aneshesiologists(ASA)physical status classification system is grade I-III;

3. Elective surgery is proposed

4. BMI of 19-30 kg/m2;

5. Patients who agreed to enroll in this study voluntarily

Exclusion Criteria:

1. Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;

2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;

3. History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery

4. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;

5. Respiratory insufficiency, respiratory failure;

6. BMI<18 kg/m2 or BMI>30kg/m2;

7. Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;

8. Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7

9. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Drug:
• normal Saline
Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery
• Esketamine
Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery
• Remimazolam
Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative sleep disturbance on the first night after surgery	Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first day after surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.	the first night after surgery
Secondary	The incidence of sleep disturbance one day before surgery	Patients completed the sleep quality scales(AIS, Athens Insomnia Scale) on the day before surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire on the day before surgery to evaluate patients' preoperative sleep quality. We recorded AIS scores as statistical indicators.	one day before surgery
Secondary	The incidence of postoperative sleep disturbance on the second and third postoperative nights	Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the second and third day after surgery.The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the second and third postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.	the second and third nights after surgery
Secondary	Postoperative anxiety	Patients completed the anxiety rating scales(HADS-A,Hospital Anxiety and Depression Scale-Anxiety subscale)on the day before surgery.HADS-A consists of 7 items,each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety.And we asked the patients to fill out this questionnaire on the 1 and 2 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators.	1 day before surgery ,1 and 2 days after surgery
Secondary	Postoperative depression	Patients completed the depression rating scales(HADS-D,Hospital Anxiety and Depression Scale-Depression subscale)on the day before surgery.HADS-D consists of 7 items,each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression.And we asked the patients to fill out this questionnaire on the 1 and 2 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators.	1 day before surgery ,1 and 2 days after surgery
Secondary	Pain Score (NRS)	The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.	1 and 2 days after surgery
Secondary	Mean intraoperative blood pressure	The mean intraoperative blood pressure was recorded	Intraoperative
Secondary	Oxygen saturation	The mean intraoperative oxygen saturation was recorded	Intraoperative
Secondary	Somatokinetic reaction	The number of intraoperative body movements was recorded	Intraoperative
Secondary	Operation time	The duration of the patient's operation was recorded(up to 24 h)	Intraoperative
Secondary	Duration of anesthesia	The patient's duration of anesthesia was recorded(up to 24 h)	Intraoperative
Secondary	Time to walking down	Record the time from waking up to walking down(up to 24 h)	Within1 hour after surgery
Secondary	Adverse event	All kinds of adverse events(PONV?hypotension?hypertension,etc) occurred in patients were recorded	Within 3 days after surgery