Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol

• ClinicalTrials.gov Identifier: NCT05242081
• Recruitment Status: Recruiting
• First Posted: February 16, 2022
• Last Update Posted: February 16, 2022
• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Information provided by (Responsible Party): The First Affiliated Hospital with Nanjing Medical University

Tracking Information

• First Submitted Date: January 13, 2022
• First Posted Date: February 16, 2022
• Last Update Posted Date: February 16, 2022
• Estimated Study Start Date: February 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 7, 2022)

Incidence of hemodynamic instability [ Time Frame: From the date of the surgery until the date of the occurrence of hemodynamic instability, assessed up to 2 weeks ]

The incidence of arrythmias, hypertension or hypotension

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 7, 2022)

• Total dosage of anesthesia drug [ Time Frame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days ]
• The duration of surgery [ Time Frame: From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days ]
• Time until awake [ Time Frame: From the end of anesthesia until awake, assessed up to 2 days ]
• Time to removal of tracheal intubation [ Time Frame: From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days ]
• Incidence of postoperative nausea and vomiting [ Time Frame: 48 hours after the surgery ]
• Incidence of postoperative delirium [ Time Frame: 48 hours after the surgery ]
• Postoperative first analgesia demand [ Time Frame: From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week ]
  The first time that the patient ask for analgesia
• Visual analogue score (VAS) pain score at rest [ Time Frame: 24 hours after the surgery ]
• Visual analogue score (VAS) pain score whilst coughing [ Time Frame: 24 hours after the surgery ]
• Postoperative hospital stay [ Time Frame: From the date of the surgery until the date being discharged from hospital, up to 1 month ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol
• Official Title: The Perioperative Effect of an Opioid-free Anesthesia and Opioid Anesthesia in Short Surgery Patients: a Multi-center Prospective Randomized Controlled Trial
• Brief Summary: The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on perioperative hemodynamics in short surgical operations, and to explore the effects of esketamine on postoperative recovery time, postoperative incidence of nausea, vomiting and delirium, and postoperative pain.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Opioid Use, Unspecified
• S-ketamine

Intervention

• Drug: S-ketamine
  S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance
• Drug: Fentanyl
  Fentanyl 4μg/kg for induction and remifentanil 0.05-0.25μg/kg/min for maintenance

Study Arms

• Experimental: S-ketamine
  Intervention: Drug: S-ketamine
• Active Comparator: Fentanyl
  Intervention: Drug: Fentanyl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 7, 2022): 1400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Aged from 18 years to 70 years
2. American society of anesthesiologists physical status classification I-II
3. Patients scheduled for Orthopedic, urological or general surgery （the duration of surgery less than 1 hour）
4. Willing to sign informed consent

Exclusion Criteria:

1. Allergic to anesthesia drugs;
2. Surgical history within the past 1 month;
3. Severe heart, lung, brain, liver or kidney diseases;
4. Neurological or mental diseases under treatment;
5. Inability to understand visual analog scale (VAS).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ling Zhou; +86 15895918786; lingzhou531@foxmail.com

Contact: Chun Yang; +8618260062666; chunyang@njmu.edu.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05242081
• Other Study ID Numbers: 2021-SR-480
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: The First Affiliated Hospital with Nanjing Medical University
• Verification Date: February 2022