Intravenous Dexmedetomidine for Cesarean Section

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065530
• Other study ID #: 2015-SR-203
• Status: Completed
• Phase: Phase 4
• Start date: February 7, 2017
• Est. completion date: October 5, 2017

Study information

• Verified date: January 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 5, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia Obstetrical
• Breast Feeding
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest	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	Relative Infant Dose (RID) of Dexmedetomidine	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest	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.
Secondary	Ramsay Sedation Score(RSS)	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.
Secondary	The Degree of Satisfaction	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.
Secondary	Number of Participants That Experienced Nausea or Vomiting	Total times during 48h after cesarean section.	48h after cesarean section.
Secondary	Ramsay Sedation Score(RSS)	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.
Secondary	Ramsay Sedation Score(RSS)	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.
Secondary	Ramsay Sedation Score(RSS)	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS)	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping	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.
Secondary	Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping	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.