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

May 6, 2021 updated by: Nie Yuyan, Obstetrics & Gynecology Hospital of Fudan University
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

Study Overview

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200090
        • Obstetrics & Gynecology Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
Control Group receives normal saline bolus after delivery
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.
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
sufentanil combined with dexmedetomidine PCA after surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Ramsay sedation score (RSS)
Time Frame: At 4, 8 and 24 h after surgery
Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery.
At 4, 8 and 24 h after surgery
Changes in systolic blood pressure
Time Frame: 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.
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
Time Frame: During 24h after surgery
The total press times and invalid press times are recorded during 24h after surgery.
During 24h after surgery
Changes in heart rate (HR)
Time Frame: 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.
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)
Time Frame: 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
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Changes in diastolic blood pressure
Time Frame: 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.
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
Time Frame: 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.
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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