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
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Ling Dong |
China,
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
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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