A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Normal saline; Drug: Dexmedetomidine; Drug: Sufentanil; Drug: Sufentanil and dexmedetomidine

• Registration Number: NCT02741219
• Lead Sponsor: Obstetrics & Gynecology Hospital of Fudan University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Normal saline	Parturients in this group receive 20ml intravenous normal saline immediately after delivery. Their patient controlled analgesia (PCA) protocol after surgery consists of 100 mcg sufentanil diluted into 100ml and administer at a background infusion of 1ml/h,and a bolus of 2ml, with a lock-out of 8min.
Control Group	Sufentanil	Parturients in this group receive 20ml intravenous normal saline immediately after delivery. Their patient controlled analgesia (PCA) protocol after surgery consists of 100 mcg sufentanil diluted into 100ml and administer at a background infusion of 1ml/h,and a bolus of 2ml, with a lock-out of 8min.
Dex Group	Sufentanil and dexmedetomidine	Parturients in this group receive 0.5mcg/kg intravenous dexmedetomidine diluted to 20ml with normal saline. Their PCA protocol after surgery is 100mcg sufentanil and 300mcg dexmedetomidine diluted to 100ml in saline, with the continuous infusion of 1ml/h, and a bolus of 2 ml, with a lock-out of 8min.
Dex Group	Dexmedetomidine	Parturients in this group receive 0.5mcg/kg intravenous dexmedetomidine diluted to 20ml with normal saline. Their PCA protocol after surgery is 100mcg sufentanil and 300mcg dexmedetomidine diluted to 100ml in saline, with the continuous infusion of 1ml/h, and a bolus of 2 ml, with a lock-out of 8min.

Primary Outcome Measures

Name	Time	Method
Changes in pain score	At 0, 4, 8 and 24 h after surgery	Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).
Sufentanil consumption	During 24h after surgery	The total consumption of sufentanil during 24h after surgery are recorded.

Secondary Outcome Measures

Name	Time	Method
Changes in heart rate (HR)	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery	HR is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
Changes in systolic blood pressure	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.	Systolic blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
Changes in Ramsay sedation score (RSS)	At 4, 8 and 24 h after surgery	Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery.
Press times of analgesic pump	During 24h after surgery	The total press times and invalid press times are recorded during 24h after surgery.
Changes in saturation of blood oxygen (SpO2)	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery	SpO2 is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery
Changes in diastolic blood pressure	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery	Diastolic blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
Changes in mean arterial blood	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery	Mean arterial blood pressure is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.

Trial Locations

Locations (1)

Obstetrics & Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China