Dexmedetomidine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05698407

Collaborator

(none)

200

Enrollment

Arms

15.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Sufentanil is commonly used with ropivacaine in epidural labor anesthesia. However, it can cause some adverse reaction. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity, which possesses opioid-sparing and analgesic effects. Published researches have shown that the ropivacaine combined with dexmedetomidine can effectively relieve postoperative pain. The purpose of this present study is to compare the effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanil in epidural labor analgesia on neonatal outcomes, and also tested the feasibility of a future large randomized trial.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Drug: Dexmedetomidine Drug: Sufentanil Drug: Ropivacaine	Phase 2

Detailed Description

Sufentanil is commonly used with ropivacaine in epidural labor anesthesia. However, it can cause some adverse reaction including possible higher risk of neonatal distress. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity, which possesses opioid-sparing and analgesic effects. Recently, published researches have shown that the ropivacaine combined with dexmedetomidine can effectively relieve postoperative pain and labor pain.

The purpose of this present study is to compare the effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanil in epidural labor analgesia on neonatal outcomes, and also tested the feasibility of a future large randomized trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a randomized, double-blind, pilot trial with two parallel-armsa randomized, double-blind, pilot trial with two parallel-arms

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

All study participants, attending anesthesiologists, other health-care team members, and outcome assessors were blinded to the study group assignment.

Primary Purpose:

Treatment

Official Title:

Effect of Dexmedetomidine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes: a Pilot Randomized Trial

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine 0.4ug/ml dexmedetomidine plus 0.08% ropivacaine	Drug: Dexmedetomidine Drug concentration: 0.4ug/ml dexmedetomidine plus 0.08% ropivacaine. Epidural loading dose: 10-15ml. Then a programmed intermittent epidural bolus pump with 250 ml was attached 30 minutes later with 4ml/h infusion rate, 8-ml controlled boluses at a 30-min lockout interval. Drug: Ropivacaine Ropivacaine
Active Comparator: Sufentanil 0.4ug/ml sufentanil plus 0.08% ropivacaine	Drug: Sufentanil Drug concentration: 0.4ug/ml sufentanil plus 0.08% ropivacaine. Epidural loading dose: 10-15ml. Then a programmed intermittent epidural bolus pump with 250 ml was attached 30 minutes later with 4ml/h infusion rate, 8-ml controlled boluses at a 30-min lockout interval. Drug: Ropivacaine Ropivacaine

Arm

Intervention/Treatment

Experimental: Dexmedetomidine

0.4ug/ml dexmedetomidine plus 0.08% ropivacaine

Drug: Dexmedetomidine

Drug concentration: 0.4ug/ml dexmedetomidine plus 0.08% ropivacaine. Epidural loading dose: 10-15ml. Then a programmed intermittent epidural bolus pump with 250 ml was attached 30 minutes later with 4ml/h infusion rate, 8-ml controlled boluses at a 30-min lockout interval.

Drug: Ropivacaine

Ropivacaine

Active Comparator: Sufentanil

0.4ug/ml sufentanil plus 0.08% ropivacaine

Drug: Sufentanil

Drug concentration: 0.4ug/ml sufentanil plus 0.08% ropivacaine. Epidural loading dose: 10-15ml. Then a programmed intermittent epidural bolus pump with 250 ml was attached 30 minutes later with 4ml/h infusion rate, 8-ml controlled boluses at a 30-min lockout interval.

Drug: Ropivacaine

Ropivacaine

Outcome Measures

Primary Outcome Measures

Composite neonatal morbidity [24 hours after birth]
presence of 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

Secondary Outcome Measures

Duration of labor [At the time of delivery]
Duration of first and second stages of labor
Delivery mode [At the time of delivery]
The mode of delivery includes spontaneous delivery, instrumental delivery, and Cesarean delivery.
Epidural infusion volume [At the time of delivery]
Total epidural infusion volume and epidural infusion volume per hour
Subjective sleep quality score at delivery night [24 hours after birth]
Numeric Rating Scale (NRS) score of subjective sleep quality
The depression score assessed by Edinburgh Postnatal Depression Scale (EPDS) [42 days after delivery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

greater than 18 years of age; term pregnancy (greater than 37 gestational weeks); planning epidural labor analgesia; singleton pregnancy; vertex presentation; planned vaginal delivery.

Exclusion Criteria:

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.
Existence of bradycardia (heart rate < 60 bpm), hypotension (SBP < 90 mmHg) or severe hypertension (SBP ≥ 180mmHg), Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac], American Society of Anesthesiologists (ASA) Physical Status ≥ 3.
History of psychiatric disease.
Allergy to study agents.
Inability to communicate or participate in study procedures.