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

Obstetrics & Gynecology Hospital of Fudan University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Sufentanil and dexmedetomidine; Drug: Dexmedetomidine; Drug: Normal saline; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02741219

OBGynFudanU

Details and patient eligibility

About

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

Enrollment: 225 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

225 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline

Drug: Sufentanil

Dex Group

Experimental group

Description:

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.

Treatment:

Drug: Sufentanil and dexmedetomidine

Drug: Dexmedetomidine