Clinical trial NCT05242081: Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol
Official title: Efficacy and Safety of Opioid-free Anesthesia With Propofol Combined With S-ketamine in Laparoscopic Cholecystectomy: a Multicenter, Randomized, Controlled, Non-inferiority Clinical Study (SKOF - LC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use, Unspecified
S-ketamine
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on postoperative analgesia and perioperative hemodynamics in short surgical operations, and to explore the effects of S-ketamine on postoperative awakening time and extubation time, nausea and vomiting, hypoxemia, and delirium.


Eligibility criteria: Inclusion Criteria:

1. Aged from 18 years to 65 years
2. American society of anesthesiologists physical status classification I-II
3. Patients scheduled for elective laparoscopic cholecystectomy
4. Willing to sign informed consent

Exclusion Criteria:

1. Allergic to narcotic drugs;
2. Surgical history within the past 1 month;
3. patients with neurological diseases or mental disorders;
4. Unable to understand numerical rating Scale (NRS);
5. patients with untreated or poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure over 180/100mmHg);
6. patients with untreated or undertreated hyperthyroidism;
7. Patients with unstable angina pectoris or myocardial infarction in the past 6 months;
8. When intraocular pressure is high (glaucoma) and penetrating ocular trauma, intraocular pressure cannot rise.

Primary outcomes:
measure: The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
timeFrame: 1 day of the surgery
Secondary outcomes:
measure: The area under the curve (AUC) of mean arterial pressure (MAP) within 10 minutes after induction is lower than the baseline mean arterial pressure (MAP 3 minutes before induction).
timeFrame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
measure: herat rate and blood pressure during the surgery every 5 minutes
timeFrame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
measure: Total dosage of anesthesia drug
timeFrame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
measure: Total dosage of vasoactive agents
timeFrame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
measure: The duration of surgery
timeFrame: From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days
measure: Time until awake
timeFrame: From the end of anesthesia until awake, assessed up to 2 days
measure: Time to removal of tracheal intubation
timeFrame: From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days
measure: Incidence of postoperative nausea and vomiting
timeFrame: 48 hours after the surgery
measure: Incidence of postoperative delirium
timeFrame: 48 hours after the surgery
measure: Incidence of hypoxemia
timeFrame: 48 hours after the surgery
measure: Postoperative first analgesia demand
timeFrame: From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week
measure: numerical rating scale (NRS) pain score
timeFrame: 24 hours and 48 hours after the surgery
measure: Postoperative hospital stay
timeFrame: From the date of the surgery until the date being discharged from hospital, up to 1 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: