CompletedInterventionalNot ApplicableUpdated Feb 16, 2021
A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section | NCT02741219 | Trialant
CompletedInterventionalPhase 4Updated May 7, 2021
A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
ClinicalTrials.gov ID
NCT02741219
Lead Sponsor
Obstetrics & Gynecology Hospital of Fudan UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
225Actual
Last Update Posted
May 7, 2021Actual
Start Date
Nov 2015Actual
Primary Completion Date
Jan 2016Actual
Completion Date
Jan 2016Actual
Brief Summary
The purpose of this multicenter study is to evaluate the effectiveness and safety of dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean section
Postoperative Pain
Normal saline
Dexmedetomidine
Sufentanil
Sufentanil and dexmedetomidine
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parturients undergoing elective caesarean delivery under spinal anaesthesia
American Society of Anesthesiologists class I and II parturients aged 18-45 years, with term singleton pregnancies
Parturients with the ability to understand verbal and written mandarin
Parturients who want to use PCA intravenous analgesia and can use the pump correctly
Parturients whose written informed consent have been obtained
Exclusion Criteria:
A history of allergy to dexmedetomidine or other study drugs
A long use history of opioid analgesic, NSAIDs, tranquilliser use
Psychiatric disorders
A history of neuromuscular and endocrine disease or allergic disease
A history of lower abdominal surgery
Preoperative heart rate (HR) less than 50 bpm, SBP less than 100 mmHg or cardiac conduction or rhythm abnormalities
spinal anaesthesia was unsuccessful or an epidural catheter had to be used to achieve adequate anaesthesia
A second operation is required during the study.
Participating other study during the latest three months
Body mass index more than 30 kg/m2
Difficult airway ( Mallampati score more than 3 and anatomic deformity )
Not suitable for participation estimated by investigation
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
No central contacts
There are no central contacts for this study.
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality 200090, China
Lead Sponsor
Obstetrics & Gynecology Hospital of Fudan UniversityOTHER