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

Cesarean Section Clinical Trial

Official title:

The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299866
• Other study ID #: YXLL-KY-2021(071)
• Status: Recruiting
• Phase: Phase 4
• Start date: April 12, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Qianfoshan Hospital
• Contact: Ling Dong, Ph.D
• Phone: 18866862815
• Email: dongling1668[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status 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

Related Conditions & MeSH terms

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

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.
• 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.

Locations

Country	Name	City	State
China	Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Ling Dong

Country where clinical trial is conducted

China, 

References & Publications (4)

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(12):CD012033. doi: 10.1002/14651858.CD012033.pub4. — View Citation

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. — View Citation

Isik 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The total number of presses of Patient-controlled Analgesia (PCA)	The total number of presses of PCA	Up to 48 hours after surgery
Other	The percentage of using rescue analgesics	The percentage of using rescue analgesics	Up to 48 hours after surgery
Other	The Richmond Agitation-Sedation Scale(RASS)	Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)	Hour 12 & Hour 24 & Hour 48 after surgery
Other	The incidence of postoperative adverse event	postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc	Up to 48 hours after surgery
Primary	The percentage of patients with moderate-to-severe pain	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.	Up to 48 hours after surgery
Secondary	NRS pain score at rest and with movement	Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)	Hour 12 & Hour 24 & Hour 48 after surgery