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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

Z

Zhuan Zhang

Status

Completed

Conditions

Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery

Treatments

Drug: esketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT05715671
20221217

Details and patient eligibility

About

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.

Enrollment

138 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

138 participants in 3 patient groups

Esketamine for induction 0.15mg/kg and maintenance 0.15mg/kg/h
Experimental group
Treatment:
Drug: esketamine
Esketamine for induction 0.3mg/kg and maintenance 0.3mg/kg/h
Experimental group
Treatment:
Drug: esketamine
No esketamine
No Intervention group

Trial contacts and locations

1

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Central trial contact

zhuan zhang, professor

Data sourced from clinicaltrials.gov

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