Postoperative PainPhase 4NCT02741219
A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
A Phase 4 study testing Normal saline, Dexmedetomidine and Sufentanil in people with Postoperative Pain, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Normal saline, Dexmedetomidine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
About this study
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
- Being tested
- Normal saline, Dexmedetomidine, Sufentanil, Sufentanil and dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Control Group receives normal saline bolus after delivery
DexmedetomidineDrug
Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
SufentanilDrug
sufentanil PCA after surgery
Sufentanil and dexmedetomidineDrug
sufentanil combined with dexmedetomidine PCA after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmedetomidine; Drug: Sufentanil and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufentanil consumption
The total consumption of sufentanil during 24h after surgery are recorded.
Measured: During 24h after surgery
Changes in pain score
Pain scores at rest and movement are evaluated with a visual analogue scale (VAS).
Measured: At 0, 4, 8 and 24 h after surgery
Secondary outcomes (7)
Changes in Ramsay sedation score (RSS)
Sedation intensity measured with RSS is recorded at the 4, 8 and 24 h after surgery.
Measured: At 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
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.
Measured: 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.
Measured: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nie Yuyan, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741219
- Sponsor's protocol ID
- OBGynFudanU
- Status last verified
- May 2021
- First submitted
- 11 Mar 2016
- Last updated
- 7 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
- ClinicalTrials.gov ID
- NCT02741219
- Acronym / sponsor ID
- OBGynFudanU
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Normal saline, Drug: SufentanilParturients 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. |
| Dex Group | Experimental | Drug: Dexmedetomidine, Drug: Sufentanil and dexmedetomidineParturients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineControl Group receives normal saline bolus after delivery | Drug | Control Group |
| DexmedetomidineDex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery | Drug | Dex Group |
| Sufentanilsufentanil PCA after surgery | Drug | Control Group |
| Sufentanil and dexmedetomidinesufentanil combined with dexmedetomidine PCA after surgery | Drug | Dex Group |
Primary outcome
Sufentanil consumption
Time frame: During 24h after surgery
The total consumption of sufentanil during 24h after surgery are recorded.
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).
7 secondary outcomes
Changes in Ramsay sedation score (RSS)
Time frame: 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.
Press times of analgesic pump
Time frame: 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal saline, Dexmedetomidine and Sufentanil in people with Postoperative Pain, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sufentanil consumption (time frame: During 24h after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.