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Completed

NCT Number: NCT05715671

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

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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Key information

Conditions

Patients Undergoing General Anesthesia Laparoscopic Uterine Surgery Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient refusal;
  • Known allergy to anesthetic drugs;
  • Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] > 7);
  • 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;
  • Long-term use of opioids or sedative-hypnotic drugs;
  • History of psychiatric or neurological disease;
  • Previous or planned neurosurgery.

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

Treatment and study plan

Esketamine

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.

Primary outcomes

  1. Changes in the level of actigraphy

    Time frame: Baseline (the night before surgery), postoperative nights 1 and 2

    Through the actigraphy, monitor the patient's sleep quality.

  2. Changes in the level of Pittsburgh sleep quality index

    Time frame: Baseline (the night before surgery), postoperative nights 1, 2 and 3

    Assess the patient's sleep quality by asking questions on the scale on a scale of 0-21, with higher scores representing poorer sleep quality.

Secondary outcomes

  1. Changes in the level of Mean Arterial Pressure

    Time frame: Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit

    The outcome above should be measured at the time before induction, after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit.

  2. Changes in the level of IL-6

    Time frame: Preoperatively, upon surgery completion, postoperative day 1

    The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.

  3. Changes in the level of Melatonin

    Time frame: Preoperatively, upon surgery completion, postoperative day 1

    The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.

  4. Changes in the level of BDNF

    Time frame: Preoperatively, upon surgery completion, postoperative day 1

    The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.

  5. Changes in the level of IL-10

    Time frame: Preoperatively, upon surgery completion, postoperative day 1

    The above results should be measured preoperatively, upon surgery completion, and on the 1st postoperative day.

  6. Changes in the level of Heart Rate

    Time frame: Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit

    The outcome above should be measured at the time before induction, after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit.

  7. Changes in the level of Oxygen saturation

    Time frame: Baseline (before induction), after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit

    The outcome above should be measured at the time before induction, after loading dose of intervention, at the beginning of surgery, upon surgery completion, immediately after extubation, and 30min after transfer to the post-anesthesia care unit.

  8. Changes in the level of the visual analogue scale

    Time frame: Postoperative days 1 and 2

    Assess the patient's pain by asking on a scale of 0-10, with higher scores representing more severe pain.

  9. Recovery of gastrointestinal function

    Time frame: Postoperative first 1 day

    Record the time of the first postoperative exhausting

  10. Recovery of gastrointestinal function

    Time frame: Postoperative first 1 day

    Record the time of the first postoperative bowel movement

  11. Recovery of gastrointestinal function

    Time frame: Postoperative first 1 day

    Record the time of the first postoperative feeding

  12. Postoperative adverse reactions

    Time frame: Postoperative day 1

    Record the occurrence of adverse reactions (nausea and vomiting, nightmares, dizziness, and mirages) on the 1st postoperative day.

Sponsors and collaborators

Lead sponsor

Zhuan Zhang

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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