The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section
NCT ID: NCT05299866
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
216 participants
INTERVENTIONAL
2022-04-12
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of S-ketamine in Cesarean Section Combined Anesthesia
NCT05414006
The Efficacy and Safety of S-ketamine in Elective Cesarean Section
NCT04657107
Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients
NCT05826327
IV and Intrathecal Ketamine in Cesarean Section
NCT05679375
Postoperative Analgesic Effect of Esketamine
NCT05582135
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
S-ketamine group
The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
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.
Control group
The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged between 20 and 40 years
* 18 kg/m² ≤BMI≤30 kg/m²
* singleton term pregnancy
* scheduled for elective cesarean section
Exclusion Criteria
* 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
20 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ling Dong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ling Dong
clinical professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YXLL-KY-2021(071)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.