Intravenous Dexmedetomidine for Cesarean Section

January 10, 2020 updated by: Shijiang Liu, The First Affiliated Hospital with Nanjing Medical University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group

The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery.

Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Drug: Normal Saline
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
Experimental: Dexmedetomidine 0.03ug/kg/h group

This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.

Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Drug: Dexmedetomidine 0.03ug/kg/h
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 Hydrochloride
  • dexmedetomidine Injection
Experimental: Dexmedetomidine 0.05ug/kg/h group

This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.

Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Drug: Dexmedetomidine 0.05ug/kg/h
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 Hydrochloride
  • dexmedetomidine Injection
Experimental: Dexmedetomidine 0.08ug/kg/h group

This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery.

Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Drug: Dexmedetomidine 0.08ug/kg/h
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 Hydrochloride
  • dexmedetomidine Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6h after cesarean section.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48h after cesarean section.
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
12h after cesarean section.
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).
6h after cesarean section.
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.
48h after cesarean section.
Number of Participants That Experienced Nausea or Vomiting
Time Frame: 48h after cesarean section.
Total times during 48h after cesarean section.
48h after cesarean section.
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).
12h after cesarean section.
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).
24h after cesarean section.
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).
48h after cesarean section.
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
24h after cesarean section.
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
48h after cesarean section.
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.
6h after cesarean section.
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.
12h after cesarean section.
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.
24h after cesarean section.
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.
48h after cesarean section.
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
6h after cesarean section.
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
12h after cesarean section.
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
24h after cesarean section.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 5, 2017

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-SR-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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