Evaluation of Different Anesthesia for Uterine Curettage

Abortion, Induced Clinical Trial

— EDAUC  

Official title:

Evaluation of the Anesthetic Efficacy of Propofol,Sevoflurane and Paracervical Block for Uterine Curettage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733564
• Other study ID #: NMU-FY2008-209
• Secondary ID: NJFY0890-MZ12
• Status: Completed
• Phase: N/A
• First received: August 11, 2008
• Last updated: March 30, 2009
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• ASA status I-II

• Performing abortion operation (medical- or surgical)

• Requiring painless abortion

Exclusion Criteria:

• < 19 yrs, and >=45 yrs

• History of central active drugs administration

• Drug abuse

• Hypertension

• Diabetes

• Any other chronic diseases

• Allergy to the study drugs

• Habit of over-volume alcohol drinking

• Records of history of centrally active drug use and psychiatry

• Any organic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced
• Uterine Curettage

Intervention

Drug:
• Lidocaine
Paracervical injection of 2% Lidocaine to block associated nociception input
• Propofol
Propofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia
• Sevoflurane
Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bispectral Index (BIS) value		0, 5, 10, 20, 30min after anesthesia	Yes
Secondary	Intraoperative awareness		0, 5, 10, 20, 30min after anesthesia	Yes
Secondary	Vital signs		0, 5, 10, 15, 20, 25, 30min after anesthesia	Yes
Secondary	Arterial blood gas analysis		5min before operation; 1min and 5min after beginning of the operation	Yes
Secondary	Pain intensity		0, 5, 10, 20, 30min after surgical procedures	Yes
Secondary	Cortisol level		30min before operation; 1 and 5min during operation	No
Secondary	Side effects		30min after operation	Yes
Secondary	Uterine bleeding		0min after completion of the operation; 1 hour after the operation	Yes