Clinical trial NCT02741219: A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Parturients undergoing elective caesarean delivery under spinal anaesthesia
2. American Society of Anesthesiologists class I and II parturients aged 18-45 years, with term singleton pregnancies
3. Parturients with the ability to understand verbal and written mandarin
4. Parturients who want to use PCA intravenous analgesia and can use the pump correctly
5. Parturients whose written informed consent have been obtained

Exclusion Criteria:

1. A history of allergy to dexmedetomidine or other study drugs
2. A long use history of opioid analgesic, NSAIDs, tranquilliser use
3. Psychiatric disorders
4. A history of neuromuscular and endocrine disease or allergic disease
5. A history of lower abdominal surgery
6. Preoperative heart rate (HR) less than 50 bpm, SBP less than 100 mmHg or cardiac conduction or rhythm abnormalities
7. spinal anaesthesia was unsuccessful or an epidural catheter had to be used to achieve adequate anaesthesia
8. A second operation is required during the study.
9. Participating other study during the latest three months
10. Body mass index more than 30 kg/m2
11. Difficult airway ( Mallampati score more than 3 and anatomic deformity )
12. Not suitable for participation estimated by investigation

Primary outcomes:
measure: Sufentanil consumption
timeFrame: During 24h after surgery
measure: Changes in pain score
timeFrame: At 0, 4, 8 and 24 h after surgery
Secondary outcomes:
measure: Changes in Ramsay sedation score (RSS)
timeFrame: At 4, 8 and 24 h after surgery
measure: Changes in systolic blood pressure
timeFrame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
measure: Press times of analgesic pump
timeFrame: During 24h after surgery
measure: Changes in heart rate (HR)
timeFrame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
measure: Changes in saturation of blood oxygen (SpO2)
timeFrame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
measure: Changes in diastolic blood pressure
timeFrame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
measure: Changes in mean arterial blood
timeFrame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
References: