Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03622047

Enrollment

1800

Registered

2018-08-09

Start date

2018-08-15

Completion date

2020-08-01

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacological Action

Keywords

Labor, Analgesia, Dexmedetomidine, Sufentanil

Brief 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.

Detailed 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.

Interventions

DRUGDexmedetomidine 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.

DRUGNo analgesia labor

No analgesia labor control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 42 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The onset time	30 minutes	A drug's effects to come to prominence upon administration.

Secondary

Measure	Time frame	Description
analgesic effect	1 day	VAS Score Visual analogue scale (VAS) of pain before and after analgesia

Countries

China

Contacts

Primary Contactzeyong yang, MD, PhD

zeyongy2018@aliyun.com86-21-64070434

Backup ContactQiong Meng, MD

yankylge@aliyun.com86-21-64075389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026