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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01806155
Other study ID # 734/2555(EC2)
Secondary ID
Status Recruiting
Phase N/A
First received March 3, 2013
Last updated August 16, 2013
Start date March 2013
Est. completion date October 2014

Study information

Verified date August 2013
Source Mahidol University
Contact Sirilak Suksompong, MD
Phone 6624113256
Email sirilak.suk@mahidol.ac.th
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

Headache after major craniotomy may be a problem in taking care of the patients. The investigators want to identify the incidence of headache after major craniotomy and also the risk factors.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient undergoing major craniotomy

Exclusion Criteria:

- emergency surgery or traumatic patients

- may need postoperative ventilatory support more than 2 days

- cannot communicate

- psychiatric patients

- chronic use of benzodiazepine or drug abuse

- cannot follow the treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of headache after major craniotomy By asking the patients about the symptoms 3 months Yes
Secondary risk factors of headache after major craniotomy such as sex, education by collecting the patients data 3 months Yes
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