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CompletedNCT02741219Updated May 7, 2021

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

A Phase 4 interventional study of Normal saline and Dexmedetomidine in Postoperative Pain, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-05-07.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2015, registered Mar 2016).
Phase
Phase 4
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 225 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 23 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
225 participants (actual)

Study arms

  • 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.

    Drug: Normal saline · Drug: Sufentanil

  • 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.

    Drug: Dexmedetomidine · Drug: Sufentanil and dexmedetomidine

Interventions

  • DrugNormal saline

    Control Group receives normal saline bolus after delivery

  • DrugDexmedetomidine

    Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery

  • DrugSufentanil

    sufentanil PCA after surgery

  • DrugSufentanil and dexmedetomidine

    sufentanil combined with dexmedetomidine PCA after surgery

06

What researchers measure

Primary outcomes

  1. Sufentanil consumption

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

    Time frame: During 24h after surgery

  2. Changes in pain score

    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 outcomes

  1. Changes in Ramsay sedation score (RSS)

    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

  2. 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.

    Time frame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery.

  3. Press times of analgesic pump

    The total press times and invalid press times are recorded during 24h after surgery.

    Time frame: During 24h after surgery

  4. 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.

    Time frame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery

  5. Changes in saturation of blood oxygen (SpO2)

    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

  6. 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.

    Time frame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery

  7. 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.

    Time frame: At 0 min, 5 min, 10 min, 30 min after intervention during surgery and at 8h,24 h after surgery

07

Study locations

1 site
  • Obstetrics & Gynecology Hospital of Fudan University
    Shanghai, Shanghai 200090, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02741219
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Responsible party
Nie Yuyan (Associate Professor, Obstetrics & Gynecology Hospital of Fudan University) — Principal investigator
First posted
Apr 18, 2016
Start date
Nov 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
May 7, 2021
View the source record on ClinicalTrials.gov ↗

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