Skip to main content
OpenTrials
Completed

NCT Number: NCT03065530

Intravenous Dexmedetomidine for Cesarean Section

Nervous, anxiety, fear and other psychological reactions always appears in parturients during cesarean section. This study intends to investigate the effectiveness and safety of dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and breastfeeding after caesarean section.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Feeding Agnosia Analgesia Obstetrical Behavior Feeding Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

24 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
  • Parturients undergoing elective caesarean delivery under epidural anaesthesia
  • ASA I and II parturients aged 18-45 years, with singleton gestation.
  • Parturients with verbal and written mandarin
  • Parturients who want to use PCA intravenous analgesia and can use the pump correctly
  • written informed consent.

Exclusion criteria

  • Multiple gestation.
  • A history of allergy to dexmedetomidine or other study drugs
  • Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)
  • Opioid drugs abuse.
  • BMI more than 35 kg/m2
  • Conditions that preclude spinal anesthesia.
  • Preeclampsia or epilepsy.
  • A history of neuromuscular disease.
  • Epidural anaesthesia was unsuccessful.
  • The parturients, whose surgery ended after 11 a.m.

Treatment and study plan

normal saline

Drug

Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.

Dexmedetomidine 0.03ug/kg/h

Drug

Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.

Other names: dexmedetomidine Injection, Dexmedetomidine Hydrochloride

Dexmedetomidine 0.05ug/kg/h

Drug

Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.

Other names: dexmedetomidine Injection, Dexmedetomidine Hydrochloride

Dexmedetomidine 0.08ug/kg/h

Drug

Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.

Other names: dexmedetomidine Injection, Dexmedetomidine Hydrochloride

Primary outcomes

  1. Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest

    Time frame: 6h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position

Secondary outcomes

  1. Relative Infant Dose (RID) of Dexmedetomidine

    Time frame: 48h after cesarean section.

    Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1).

  2. Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest

    Time frame: 12h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position

  3. Ramsay Sedation Score(RSS)

    Time frame: 6h after cesarean section.

    Sedation intensity measured with RSS is recorded at the 6, 12 24 and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).

  4. The Degree of Satisfaction

    Time frame: 48h after cesarean section.

    The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported.

  5. Number of Participants That Experienced Nausea or Vomiting

    Time frame: 48h after cesarean section.

    Total times during 48h after cesarean section.

  6. Ramsay Sedation Score(RSS)

    Time frame: 12h after cesarean section.

    Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).

  7. Ramsay Sedation Score(RSS)

    Time frame: 24h after cesarean section.

    Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).

  8. Ramsay Sedation Score(RSS)

    Time frame: 48h after cesarean section.

    Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).

  9. Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest

    Time frame: 24h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position

  10. Postoperative Pain Score (Visual Analogue Scale, VAS)

    Time frame: 48h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position

  11. Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement

    Time frame: 6h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.

  12. Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement

    Time frame: 12h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.

  13. Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement

    Time frame: 24h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.

  14. Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement

    Time frame: 48h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.

  15. Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping

    Time frame: 6h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position

  16. Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping

    Time frame: 12h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position

  17. Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping

    Time frame: 24h after cesarean section.

    visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Jan 13, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.