Back to resultsA Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Normal saline
Dexmedetomidine
Sufentanil
Sufentanil and dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Obstetrics & Gynecology Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Dex Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Sufentanil consumption
The total consumption of sufentanil during 24h after surgery are recorded.
Changes in pain score
Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).
Secondary Outcome Measures
Changes in Ramsay sedation score (RSS)
Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery.
Changes in systolic blood pressure
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.
Press times of analgesic pump
The total press times and invalid press times are recorded during 24h after surgery.
Changes in heart rate (HR)
HR is recorded 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)
SpO2 is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery
Changes in diastolic blood pressure
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.
Changes in mean arterial blood
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.
Full Information
NCT ID
NCT02741219
First Posted
March 11, 2016
Last Updated
May 6, 2021
Sponsor
Obstetrics & Gynecology Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT02741219
Brief Title
A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obstetrics & Gynecology Hospital of Fudan University
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Dex Group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Control Group receives normal saline bolus after delivery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
sufentanil PCA after surgery
Intervention Type
Drug
Intervention Name(s)
Sufentanil and dexmedetomidine
Intervention Description
sufentanil combined with dexmedetomidine PCA after surgery
Primary Outcome Measure Information:
Title
Sufentanil consumption
Description
The total consumption of sufentanil during 24h after surgery are recorded.
Time Frame
During 24h after surgery
Title
Changes in pain score
Description
Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).
Time Frame
At 0, 4, 8 and 24 h after surgery
Secondary Outcome Measure Information:
Title
Changes in Ramsay sedation score (RSS)
Description
Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery.
Time Frame
At 4, 8 and 24 h after surgery
Title
Changes in systolic blood pressure
Description
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.
Time Frame
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
Title
Press times of analgesic pump
Description
The total press times and invalid press times are recorded during 24h after surgery.
Time Frame
During 24h after surgery
Title
Changes in heart rate (HR)
Description
HR is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.
Time Frame
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Title
Changes in saturation of blood oxygen (SpO2)
Description
SpO2 is recorded at 0 min, 5 min, 10 min, 30 min after intervention during surgery
Time Frame
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Title
Changes in diastolic blood pressure
Description
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.
Time Frame
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Title
Changes in mean arterial blood
Description
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.
Time Frame
At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Obstetrics & Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
12. IPD Sharing Statement
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A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
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