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NCT Number: NCT06976996

Efficacy of Esketamine Combined With Different General Anesthetics on Quality of Postoperative Recovery

To explore the effect of subanesthetic-dose esketamine combined with different general anesthetic drugs on the quality of postoperative recovery in patients undergoing painless gastrointestinal endoscopy.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 22500, China

About this study

In this study, we planned to conduct a single-center, prospective, randomized, controlled, double-blind clinical trial to explore the effect of subanesthetic dose esketamine combined with different general anesthesia drugs on the postoperative recovery quality of patients undergoing painless gastrointestinal endoscopy combined with several commonly used intravenous general anesthesia drugs, aiming at gastroscopy combined with colonoscopy, a representative type of diagnosis and treatment of painless and comfortable anesthesia, and to provide more evidence-based medical evidence for clinical work.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) Aged between 18 and 75 years old (inclusive); (2) ASA (American Society of Anesthesiologists) physical status classification of Class I to III; (3) Body Mass Index (BMI) ranging from 18 to 30 kg/m²; (4) Individuals scheduled to undergo combined gastroscopy and colonoscopy under painless anesthesia; (5) Those with a patent airway and no history of difficult intubation or difficult airway management; (6) Individuals with intact cognitive function, who have provided informed consent, voluntarily participate in this study, and are capable of cooperating to complete data collection.

Exclusion criteria

  • (1)A history of unregulated diabetes mellitus, hypertension, or hypotension; (2)Concomitant hyperthyroidism or hypothyroidism; (3)Concomitant psychiatric or neurological disorders; (4)Severe hepatic or renal insufficiency; (5)Concomitant glaucoma, severe hearing or visual impairment that hinders cooperation; (6)Individuals with significant organ dysfunction; (7)Those with allergies to or contraindications for the study drug; (8)Patients with aneurysmal vascular diseases involving the thoracic or abdominal aorta, intracranial arteries, or peripheral arterial vessels; (9)Individuals who are unable to cooperate in completing the Quality of Recovery-15 (QoR-15) questionnaire.

Treatment and study plan

normal saline

Drug

normal saline (0.15 ml/kg)

Esketamine

Drug

esketamine (0.15 mg/kg)

Other names: S-ketamine

Propofol

Drug

propofol (2 mg/kg)

etomidate-ciprofol (EC) mixture

Drug

etomidate-ciprofol (EC) mixture (0.2 ml/kg)

ciprofol

Drug

ciprofol (0.5 mg/kg)

etomidate-propofol (EP) mixture

Drug

etomidate-propofol (EP) mixture (0.2 ml/kg)

Primary outcomes

  1. Quality of Recovery-15

    Time frame: Postoperative day 1 and 3

    The QoR-15 (Quality of Recovery-15) evaluates the quality of recovery across five dimensions: physical comfort (50 points), emotional state (40 points), physical independence (20 points), psychological support (20 points), and pain (20 points). The total score of the QoR-15 ranges from 0 (indicating the poorest quality of recovery) to 150 (representing the best quality of recovery).

Secondary outcomes

  1. Perioperative vital signs

    Time frame: Perioperative

    The following parameters: Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Heart Rate (HR), and Peripheral Oxygen Saturation (SpO₂) were measured and recorded at the following time points: before anesthesia induction (T0), immediately after anesthesia induction (T1), at the moment when the gastroscope entered the larynx (T2), when the gastroscope was withdrawn from the pharyngeal cavity (T3), when the colonoscope entered the anus (T4), and at the completion of colonoscopy (T5).

  2. Anesthesia Recovery Time

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

    The time interval between the last administration of general anesthetic agent(s) and the moment when the patient achieves a Modified Aldrete Score of ≥9.

  3. Procedure Duration

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

    From the beginning of gastroscopy to the end of colonoscopy withdrawal

  4. PACU residence time

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

    The time from entering the PACU to leaving the PACU after the end of gastroscopy combined with colonoscopy;

  5. Anesthetic drug use

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

    Total amount of sedative medication used, number of cases of norepinephrine, and number of cases of remifentanil.

  6. The way the patient leaves the endoscopy center

    Time frame: Postoperative

    The way in which the patient is discharged from the PACU after the anesthesia resuscitation is up to standard;

  7. The length of the patient's stay in the hospital after leaving the endoscopy center in the PACU

    Time frame: Postoperative

    The length of the patient's stay in the hospital from the time the patient leaves the PACU until he leaves the hospital.

  8. The way the patient leaves the hospital

    Time frame: Postoperative

    The patient's method of leaving the hospital, such as walking on their own, driving any means of transportation, etc.

  9. Satisfaction score

    Time frame: Postoperative

    Patient, anesthesiologist, and digestive endoscopist satisfaction with the whole gastroscopy combined with colonoscopy. Using the NRS, eleven numbers from 0-10 represent satisfaction, with 0 being dissatisfied and 10 being the most satisfied.

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

Efficacy of Subanesthetic Dose of Esketamine Combined With Different General Anesthetics on Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 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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