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NCT Number: NCT06108830

Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients

To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location status: Recruiting

Location contact

Guolin Wang

CONTACT

+8618604755166

About this study

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 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 and anxiety is worth exploring.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20-65 years old;
  • ASA classification is grade I-III;
  • Elective surgery is proposed
  • BMI of 19-30 kg/m2;
  • Patients who agreed to enroll in this study voluntarily

Exclusion criteria

  • Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
  • Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
  • 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;
  • ASA rating of IV or V;
  • Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
  • History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
  • Respiratory insufficiency, respiratory failure;
  • Patients who refused to use intravenous PCA for analgesia;
  • Pregnant or lactating women;
  • BMI<18 kg/m2 or BMI>30kg/m2;
  • 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;
  • Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Treatment and study plan

Esketamine

Drug

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began

Other names: Group of patients undergoing gastroenteroscopies with esketamine

Remimazolam

Drug

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Other names: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Esketamine and remimazolam

Drug

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Other names: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg, esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began

normal saline

Drug

Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began

Other names: Group of patients undergoing gastroenteroscopies with normal saline

Primary outcomes

  1. Sleep disturbance and anxiety after surgery

    Time frame: 1 day before surgery, 1 and 3 days after surgery

    Patients completed the sleep quality (AIS, Athens Insomnia Scale) and anxiety (Hospital Anxiety and Depression Scale) rating scales on the day before surgery. HADS consists of 14 items to calculate the patient's comprehensive score, including 7 anxiety related scores and 7 depression related scores. Each question in the questionnaire was scored on a scale of 0-3, so patients scored 0-21 on both anxiety and depression. Scores of 8 points or higher are diagnosed as depression or anxiety.And we asked the patients to fill out these questionnaires on the day 1 and 3 after surgery again to evaluate the changes in sleep quality and anxiety. (The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia). . We recorded AIS scores, HDS-A scores and HDS-D scores as separate statistical indicators.

Secondary outcomes

  1. Pain Score (NRS)

    Time frame: 1 and 3 days after surgery

    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.

  2. Incidence of injection pain

    Time frame: Intraoperative

    The frequency of injection pain induced by propofol was recorded

  3. Dosage of drug

    Time frame: Intraoperative

    The dosage of propofol, esketamine and remimazolam were recorded

  4. Mean intraoperative blood pressure

    Time frame: Intraoperative

    The mean intraoperative blood pressure was recorded

  5. Oxygen saturation

    Time frame: Intraoperative

    The mean intraoperative oxygen saturation was recorded

  6. Somatokinetic reaction

    Time frame: Intraoperative

    The number of intraoperative body movements was recorded

  7. Operation time

    Time frame: Intraoperative

    The duration of the patient's operation was recorded(up to 24 h)

  8. Duration of anesthesia

    Time frame: After surgery

    The patient's duration of anesthesia was recorded(up to 24 h)

  9. Time of awakening

    Time frame: After surgery

    The duration from the end of anesthesia to recovery was recorded(up to 24 h)

  10. Time to walking down

    Time frame: After surgery

    Record the time from waking up to walking down(up to 24 h)

  11. Adverse event

    Time frame: Within 3 days after surgery

    All kinds of adverse events occurred in patients were recorded

  12. Exhaust time

    Time frame: Within 3 days after surgery

    Records from end of anesthesia to patients with postoperative exhaust time for the first time

Study contacts

Contact information is provided by the study sponsor or research team.

Guolin Wang, MD

CONTACT

[email protected]

+8615822855556

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Sep 4, 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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