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

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741219
• Other study ID #: OBGynFudanU
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2021
• Source: Obstetrics & Gynecology Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Normal saline
Control Group receives normal saline bolus after delivery
• Dexmedetomidine
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
• Sufentanil
sufentanil PCA after surgery
• Sufentanil and dexmedetomidine
sufentanil combined with dexmedetomidine PCA after surgery

Locations

Country	Name	City	State
China	Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrics & Gynecology Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sufentanil consumption	The total consumption of sufentanil during 24h after surgery are recorded.	During 24h after surgery
Primary	Changes in pain score	Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).	At 0, 4, 8 and 24 h after surgery
Secondary	Changes in Ramsay sedation score (RSS)	Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery.	At 4, 8 and 24 h after surgery
Secondary	Changes in systolic blood pressure	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.	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
Secondary	Press times of analgesic pump	The total press times and invalid press times are recorded during 24h after surgery.	During 24h after surgery
Secondary	Changes in heart rate (HR)	HR is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Secondary	Changes in saturation of blood oxygen (SpO2)	SpO2 is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Secondary	Changes in diastolic blood pressure	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.	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Secondary	Changes in mean arterial blood	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.	At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery