- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741219
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
Status
Completed
Conditions
Intervention / Treatment
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
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Shanghai, Shanghai, China, 200090
- Obstetrics & Gynecology Hospital of Fudan University
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-
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:
- 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
Exclusion Criteria:
- 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
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
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Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).
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At 0, 4, 8 and 24 h after surgery
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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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Dexmedetomidine
- Sufentanil
- Dsuvia
Other Study ID Numbers
- OBGynFudanU
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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