Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Pharmacological Action Clinical Trial

Official title:

Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622047
• Other study ID #: International Peace Xuhui
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2020
• Source: Fudan University
• Contact: zeyong yang, MD, PhD
• Phone: 86-21-64070434
• Email: zeyongy2018[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 42 Years

Eligibility

Inclusion Criteria:

• ASA I-?, 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.

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

Drug:
• Dexmedetomidine ropivacaine
Observing the effect of 0.5 µ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
• No analgesia labor
No analgesia labor control group

Locations

Country	Name	City	State
China	International Peace Maternity and Child Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Fudan University	Shanghai First Maternity and Infant Hospital, Women and children’s hospital of Jiaxing university

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The onset time	A drug's effects to come to prominence upon administration.	30 minutes
Secondary	analgesic effect	VAS Score Visual analogue scale (VAS) of pain before and after analgesia	1 day