The Effect of S-ketamine Combined With Sufentanil for Postoperative PCIA in Patients Following Cesarean Section

• ClinicalTrials.gov Identifier: NCT05299866
• Recruitment Status: Recruiting
• First Posted: March 29, 2022
• Last Update Posted: June 1, 2022
• Sponsor: Qianfoshan Hospital
• Information provided by (Responsible Party): Qianfoshan Hospital

Tracking Information

• First Submitted Date: February 26, 2022
• First Posted Date: March 29, 2022
• Last Update Posted Date: June 1, 2022
• Actual Study Start Date: April 12, 2022
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 18, 2022)

The percentage of patients with moderate-to-severe pain [ Time Frame: Up to 48 hours after surgery ]

Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 18, 2022)

NRS pain score at rest and with movement [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]

Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 26, 2022)

• The total number of presses of PCA [ Time Frame: Up to 48 hours after surgery ]
  The total number of presses of PCA
• The percentage of using rescue analgesics [ Time Frame: Up to 48 hours after surgery ]
  The percentage of using rescue analgesics
• The Richmond Agitation-Sedation Scale(RASS) [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
  Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)
• The incidence of postoperative adverse event [ Time Frame: Up to 48 hours after surgery ]
  postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc

Original Other Pre-specified Outcome Measures (submitted: March 18, 2022)

• The number of valid presses and total number of presses of PCA [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
  The number of valid presses and total number of presses of PCA
• The percentage of using rescue analgesics [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
  The percentage of using rescue analgesics
• The Richmond Agitation-Sedation Scale(RASS) [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
  Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)
• The incidence of postoperative adverse event [ Time Frame: Hour 12 & Hour 24 & Hour 48 after surgery ]
  postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc

Descriptive Information

• Brief Title: The Effect of S-ketamine Combined With Sufentanil for Postoperative PCIA in Patients Following Cesarean Section
• Official Title: The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section
• Brief Summary: This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• S-ketamine
• Analgesia, Patient-Controlled
• Cesarean Section

Intervention

• Drug: S-ketamine
  After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.
• Drug: Placebo
  After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.

Study Arms

• Experimental: S-ketamine group
  The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
  Intervention: Drug: S-ketamine
• Placebo Comparator: Control group
  The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
  Intervention: Drug: Placebo

Publications *

• Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12:CD012033. doi: 10.1002/14651858.CD012033.pub4.
• Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.
• İsik Y, Dag ZO, Tulmac OB, Pek E. Early postpartum lactation effects of cesarean and vaginal birth. Ginekol Pol. 2016;87(6):426-30. doi: 10.5603/GP.2016.0020.
• Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 18, 2022): 216
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• ASA physical status I-II
• Patients aged between 20 and 40 years
• 18 kg/m² ≤BMI≤30 kg/m²
• singleton term pregnancy
• scheduled for elective cesarean section

Exclusion Criteria:

• Refused to participant in this trial
• Severe heart dysfunction or pulmonary insufficiency
• Poor blood pressure control in those with hypertension (BP >160/100 mmHg in the ward)
• Previous history of Intracranial hypertension or hyperthyroidism
• Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium
• Allergy to drugs used in the study

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ling Dong, Ph.D; 18866862815; dongling1668@163.com

Contact: Ling Dong, MD; 18866862815; dongling1668@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05299866
• Other Study ID Numbers: YXLL-KY-2021(071)
• Has Data Monitoring Committee: Not Provided

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

• Plan to Share IPD: No

• Current Responsible Party: Qianfoshan Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Qianfoshan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Qianfoshan Hospital
• Verification Date: May 2022