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NCT Number: NCT06617039

The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy

To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Quality of Postoperative Recovery

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, 225001, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Scheduled painless gastroscopy examination and treatment
  • Age 60-75 years old
  • ASA grade Ⅰ-Ⅱ
  • The respiratory tract is unobstructed and there is no difficult airway
  • No history of allergy to etomidate and cyclopropofol
  • Participants with normal heart, liver, lung, and kidney functions
  • Able to complete the QoR-15, MMSE, and HADS scale assessments
  • lnformed consent, voluntary participation in the trial, and signed by the patient informed consent

Exclusion criteria

  • 1. Participants with concurrent dysfunction of major organs.
  • Participants with a history of mental illness and abuse of sedative drugs
  • Participants with allergies or contraindications to the study drugs
  • Participants with severe visual, auditory, or speech communication impairments
  • Participants with acute gastrointestinal inflammation or obstruction
  • History of uncontrolled diabetes, hypertension, and hypotension
  • Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI > 30kg/m2)
  • Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.
  • Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments

Treatment and study plan

Remifentanil and ciprofol

Drug

R group will be started with remifentanil 0.5ug/kg and ciprofol 0.4 mg/kg.

esketamine 0.3mg/kg and ciprofol

Drug

Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg.

esketamine 0.5mg/kg and ciprofol

Drug

Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg.

ciprofol

Drug

Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.

Primary outcomes

  1. postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score

    Time frame: Baseline (30 min before surgery), postoperative day 1

    Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)

Secondary outcomes

  1. postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score

    Time frame: Postoperative day 3 and 7

    Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 3(minimum value : 0, maximum value : 150, the higher the score, the better the result)

  2. Cognitive function assessment

    Time frame: Baseline (30 min before surgery), postoperative day 1,3 and 7

    A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE has a maximum total score of 30, with higher scores manifesting a better cognitive performance.

  3. Hospital anxiety and depression scale ( HADS ) score.

    Time frame: Baseline (30 min before surgery), postoperative day 1,3 and 7

    Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1,3 and 7 , a score of 8 points or higher will be diagnosed as depression or anxiety.

  4. Dosage of ciprofol

    Time frame: During endoscopic examination

    Consumption of ciprofol during endoscopic examination

  5. Heart rate (HR)

    Time frame: Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)

    Throughout the procedure, the heart rate (HR) was continuously monitored.

  6. Pulse oxygen saturation (SpO2)

    Time frame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)

    Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.

  7. Mean blood pressure (MBP)

    Time frame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)

    Throughout the procedure, the mean blood pressure (MBP) was measured at 1-minute intervals.

  8. Patient satisfaction levels

    Time frame: 30 minutes at recovery room.

    The patients express their satisfaction with procedures on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.

Other outcomes

  1. The incidence of all drug-related adverse events

    Time frame: Within 72hours after surgery

    All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am).

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
May 7, 2025

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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