Intravenous Dexmedetomidine for Cesarean Section

NCT03065530 | Completed Phase 4 Results

• 1 other identifier: 2015-SR-203
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Feeding; Analgesia Obstetrical; Postoperative Pain

Keywords

Dexmedetomidine; Butorphanol tartrate; Analgesia; Breastfeeding; Relative infant dose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Relative Infant Dose (RID) of Dexmedetomidine

  48h after cesarean section.

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

  12h after cesarean section.

• Ramsay Sedation Score(RSS)

  6h after cesarean section.

• The Degree of Satisfaction

  48h after cesarean section.

• Number of Participants That Experienced Nausea or Vomiting

  48h after cesarean section.

Study Arms (4)

control group

PLACEBO COMPARATOR

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

Dexmedetomidine 0.03ug/kg/h group

EXPERIMENTAL

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

Dexmedetomidine 0.05ug/kg/h group

EXPERIMENTAL

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

Dexmedetomidine 0.08ug/kg/h group

EXPERIMENTAL

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

Interventions

Normal Saline DRUG

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

control group

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.

Also known as: dexmedetomidine Injection, Dexmedetomidine Hydrochloride

Dexmedetomidine 0.03ug/kg/h group

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.

Also known as: dexmedetomidine Injection, Dexmedetomidine Hydrochloride

Dexmedetomidine 0.05ug/kg/h group

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.

Also known as: dexmedetomidine Injection, Dexmedetomidine Hydrochloride

Dexmedetomidine 0.08ug/kg/h group

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (30)

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MeSH Terms

Conditions

Breast Feeding; Pain, Postoperative; Agnosia

Interventions

Saline Solution; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Shijiang Liu, Dr. Mei Gao
• Organization: The First Affiliated Hospital of Nanjing Medical University

liushijiang1983@hotmail.com

+862568303569

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 28, 2017
• Study Start: February 7, 2017
• Primary Completion: September 30, 2017
• Study Completion: October 5, 2017
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Locations

CN (1)