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

NCT02741219 | Completed Phase 4

• 1 other identifier: OBGynFudanU
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Sufentanil consumption

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

  During 24h after surgery

• 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 Outcomes (7)

• Changes in Ramsay sedation score (RSS)

  At 4, 8 and 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.

• Press times of analgesic pump

  During 24h after surgery

• 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

• 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

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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; Drug: Sufentanil

Dex Group

EXPERIMENTAL

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; Drug: Sufentanil and dexmedetomidine

Interventions

Normal saline DRUG

Control Group receives normal saline bolus after delivery

Control Group

Dexmedetomidine DRUG

Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery

Dex Group

Sufentanil DRUG

sufentanil PCA after surgery

Control Group

Sufentanil and dexmedetomidine DRUG

sufentanil combined with dexmedetomidine PCA after surgery

Dex Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Study Sites (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution; Dexmedetomidine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 18, 2016
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

CN (1)