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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05299866
Other study ID # YXLL-KY-2021(071)
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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