Intravenous Dexmedetomidine for Cesarean Section

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Breast Feeding; Analgesia Obstetrical

Treatments: Drug: Dexmedetomidine 0.03ug/kg/h; Drug: Normal Saline; Drug: Dexmedetomidine 0.08ug/kg/h; Drug: Dexmedetomidine 0.05ug/kg/h

Study type: Interventional

Funder types: Other

Identifiers

NCT03065530

2015-SR-203

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 24 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 4 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline

Dexmedetomidine 0.03ug/kg/h group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine 0.03ug/kg/h

Dexmedetomidine 0.05ug/kg/h group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine 0.05ug/kg/h

Dexmedetomidine 0.08ug/kg/h group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine 0.08ug/kg/h