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

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02741219
• Collaborator: (none)
• Enrollment: 225
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 112.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Normal saline; Drug: Dexmedetomidine; Drug: Sufentanil; Drug: Sufentanil and dexmedetomidine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group 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.	Drug: Normal saline; Control Group receives normal saline bolus after delivery; Drug: Sufentanil; sufentanil PCA after surgery
Experimental: Dex Group 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.	Drug: Dexmedetomidine; Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery; Drug: Sufentanil and dexmedetomidine; sufentanil combined with dexmedetomidine PCA after surgery

Outcome Measures

Primary Outcome Measures

1. Sufentanil consumption [During 24h after surgery]

   The total consumption of sufentanil during 24h after surgery are recorded.

2. 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).

Secondary Outcome Measures

1. 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.

2. 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.

3. Press times of analgesic pump [During 24h after surgery]

   The total press times and invalid press times are recorded during 24h after surgery.

4. 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.

5. 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

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai	China	200090

Sponsors and Collaborators

• Obstetrics & Gynecology Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nie Yuyan, Associate Professor, Obstetrics & Gynecology Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT02741219
• Other Study ID Numbers: OBGynFudanU
• First Posted: Apr 18, 2016
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Pain, Postoperative; Sufentanil; Dexmedetomidine; Dsuvia

Study Results

No Results Posted as of May 7, 2021