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Completed

NCT Number: NCT02741219

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

Control Group receives normal saline bolus after delivery

Dexmedetomidine

Drug

Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery

Sufentanil

Drug

sufentanil PCA after surgery

Sufentanil and dexmedetomidine

Drug

sufentanil combined with dexmedetomidine PCA after surgery

Primary outcomes

  1. Sufentanil consumption

    Time frame: During 24h after surgery

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

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2016
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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