Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698407
• Other study ID #: 2022-368
• Status: Completed
• Phase: Phase 4
• Start date: March 16, 2023
• Est. completion date: August 28, 2023

Study information

• Verified date: December 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 28, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• Dexmedetomidine
loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine.
• Sufentanil
loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijin	Bejing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Armstrong S, Fernando R. Side Effects and Efficacy of Neuraxial Opioids in Pregnant Patients at Delivery: A Comprehensive Review. Drug Saf. 2016 May;39(5):381-99. doi: 10.1007/s40264-015-0386-5. — View Citation

Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018. — View Citation

Hussain N, Grzywacz VP, Ferreri CA, Atrey A, Banfield L, Shaparin N, Vydyanathan A. Investigating the Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Brachial Plexus Block: A Systematic Review and Meta-Analysis of 18 Randomized Controlled Trials. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):184-196. doi: 10.1097/AAP.0000000000000564. — View Citation

Lee AI, McCarthy RJ, Toledo P, Jones MJ, White N, Wong CA. Epidural Labor Analgesia-Fentanyl Dose and Breastfeeding Success: A Randomized Clinical Trial. Anesthesiology. 2017 Oct;127(4):614-624. doi: 10.1097/ALN.0000000000001793. — View Citation

Liu L, Drzymalski D, Xu W, Zhang W, Wang L, Xiao F. Dose dependent reduction in median effective concentration (EC50) of ropivacaine with adjuvant dexmedetomidine in labor epidural analgesia: An up-down sequential allocation study. J Clin Anesth. 2021 Feb;68:110115. doi: 10.1016/j.jclinane.2020.110115. Epub 2020 Nov 1. — View Citation

Qian M, Gao F, Liu J, Xu P. Dexmedetomidine versus fentanyl as adjuvants to ropivacaine for epidural anaesthesia: A systematic review and meta-analysis. Int J Clin Pract. 2021 May;75(5):e13772. doi: 10.1111/ijcp.13772. Epub 2020 Dec 20. — View Citation

Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 hours after birth
Secondary	Duration of labor	Durations of the first, second, and third stages of labor	From the begining of the first stage of labor until delivery of the placenta, up to 20 hours
Secondary	Delivery mode	The mode of delivery includes spontaneous delivery, instrumental delivery, and Cesarean delivery.	At the time of delivery
Secondary	Epidural infusion volume	Total epidural infusion volume and epidural infusion volume per hour	From the begining of epidural analgesia until childbirth, up to 20 hours
Secondary	Subjective sleep quality score at the first night after childbirth	Numeric Rating Scale (NRS) score of subjective sleep quality	Up to 24 hours after childbirth
Secondary	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.	At 42 days after childbirth