Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

Peking University First Hospital200 enrolled

Overview

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia. This pilot trial is designed to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Sufentanil combined with ropivacaine is commonly used for epidural labor anesthesia. However, this combination is associated with some adverse events including increased risk of neonatal depression. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and possesses opioid-sparing and analgesic effects when used in combination with local anesthetics. Recently published data suggest that dexmedetomidine-ropivacaine combination can effectively relieve labor pain. We suppose that, when compared with traditional sufentanil-ropivacaine combination, the dexmedetomidine-ropivacaine combination used for epidural labor analgesia may reduce sufentanil-related adverse neonatal outcomes. The purpose of this pilot trial is to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination used for epidural labor analgesia on neonatal outcomes, and also to test the feasibility of a future large randomized trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

200

Conditions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18-45 years; 2. Single term pregnancy with vertex presentation planning vaginal delivery; 3. Planning to receive epidural labor analgesia. Exclusion Criteria: 1. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy. 2. Existence of bradycardia (heart rate \<60 bpm), hypotension (SBP \<90 mmHg) or severe hypertension (SBP ≥180mmHg), uncontrolled systemic comorbidities (i.e., diabetes or hepatic, renal or cardiac disease), American Society of Anesthesiologists (ASA) physical status ≥3. 3. History of psychiatric disease or epilepsia. 4. Allergy to study agents. 5. Other conditions that are considered unsuitable for study participation.

Outcomes

Primary Outcomes

Composite neonatal morbidity

Included any of the following: 1-min or 5-min Apgar score less than 7, umbilical cord arterial PH less than 7.1, requirement for immediate assisted ventilation, neonatal intensive care unit or neonatal ward admission within 24 hours after birth.

Time frame: Up to 24 hours after birth

Secondary Outcomes

Duration of labor

Durations of the first, second, and third stages of labor

Time frame: From the begining of the first stage of labor until delivery of the placenta, up to 20 hours

Delivery mode

The mode of delivery includes spontaneous delivery, instrumental delivery, and Cesarean delivery.

Time frame: At the time of delivery

Epidural infusion volume

Total epidural infusion volume and epidural infusion volume per hour

Time frame: From the begining of epidural analgesia until childbirth, up to 20 hours

Subjective sleep quality score at the first night after childbirth

Numeric Rating Scale (NRS) score of subjective sleep quality

Time frame: Up to 24 hours after childbirth

The depression score assessed by Edinburgh Postnatal Depression Scale (EPDS)

The depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview. A score of EPDS ≥10 was set as the threshold of postpartum depression.

Time frame: At 42 days after childbirth