Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Fudan University

Status: Unknown

Conditions: Pharmacological Action

Treatments: Drug: Dexmedetomidine ropivacaine; Drug: No analgesia labor

Study type: Interventional

Funder types: Other

Identifiers

NCT03622047

International Peace Xuhui

Details and patient eligibility

About

The participants: 1800 full-term primiparas will be selected with ASA I-Ⅱgrade, 20 to 35 years old and weighing 55 to 90 kg in the investigator's hospital from may 2018 to December 2018. 1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.

Full description

1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.

Enrollment: 1,800 estimated patients

Sex: Female

Ages: 22 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I-Ⅱ, aged 22 - 42,
• gestational age ≥ 37, weight 55 - 90 kg,
• labor analgesia is required by full-term primiparas.

Exclusion criteria

• serious cardiovascular and cerebrovascular system diseases,
• bradycardia, conduction block
• fetal distress
• contraindications of intraspinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 3 patient groups

dexmedetomidine ropivacaine

Experimental group

Description:

Observing 0.5 μ g / ml dexmedetomidine + 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.

Treatment:

Drug: No analgesia labor

Drug: Dexmedetomidine ropivacaine

sufentanil ropivacaine

Experimental group

Description:

compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.

Treatment:

Drug: No analgesia labor

Drug: Dexmedetomidine ropivacaine

No analgesia labor

Experimental group

Description:

Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.

Treatment:

Drug: No analgesia labor

Drug: Dexmedetomidine ropivacaine