Effect of Subanesthetic Dose of Esketamine on Sleep Quality and Recovery of Gastrointestinal Function in Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery in the Early Postoperative Period

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2023-12-31

Brief Summary

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Patients undergoing gynecological surgery are at high risk of developing postoperative sleep disorders. Intraoperative opioid use is detrimental to the patient's postoperative recovery of gastrointestinal function. Esketamine has sedative, hypnotic, analgesic, inflammatory response suppression, and antidepressant effects. Its hypnotic mechanism may be related to its rapid blockade of NMDA receptors and hyperpolarization-activated cyclic nucleotide-gated cation channels. Also can reduce the application of perioperative opioids, which in turn promotes the recovery of gastrointestinal function in patients after surgery.

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Detailed Description

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Conditions

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Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

The corresponding esketamine dose for each group was used at the end of anesthesia induction, and esketamine was changed to the corresponding maintenance dose for each group prior to surgical skin incision.

Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

The corresponding esketamine dose for each group was used at the end of anesthesia induction, and esketamine was changed to the corresponding maintenance dose for each group prior to surgical skin incision.

No esketamine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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esketamine

The corresponding esketamine dose for each group was used at the end of anesthesia induction, and esketamine was changed to the corresponding maintenance dose for each group prior to surgical skin incision.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age between 40 and 65 years;
2. ASA class I-III;
3. Proposed laparoscopic total hysterectomy/myomectomy;
4. Operative time ≥ 1 h;
5. Body mass index of 18-30 kg/m2.

Exclusion Criteria

1. Patient refusal;
2. Known allergy to anesthetic drugs;
3. Preoperative sleep disorder (Pittsburgh Sleep Quality Index \[PSQI\] \> 7);
4. Severe hypertension, coronary artery disease, cardiac insufficiency, pulmonary hypertension, pulmonary heart disease, increased cranial pressure, increased intraocular pressure, seizures, shift work, obstructive sleep apnea syndrome;
5. Long-term use of opioids or sedative-hypnotic drugs;
6. History of psychiatric or neurological disease;
7. Previous or planned neurosurgery.

(7)hearing or visual impairment that precludes a scale assessment.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No