Drug Withdrawal HeadacheNCT02374346
Postoperative Headache in Elective Surgery Patients
An observational study of Drug Withdrawal Headache, run by Attikon Hospital.
Trial summary
To evaluate the association of anaesthesia and surgery with postoperative headache in elective surgery patients By multiple logistic regression analysis of data collected during a six-month period from 446 patients undergoing elective surgery, a prospective single centre cohort study in a university hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Withdrawal Headache
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Mar 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures
Who may be able to join
- all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures
Who cannot join
- patient refusal
- age under 18 years
- cognitive dysfunction
- head trauma or neurological disorders
- difficulty with language comprehension or any other inability to communicate verbally with the interviewer.
About this study
Official title: Factors Associated With the Presence of Postoperative Headache in Elective Surgery Patients: a Prospective Single Center Cohort Study
To evaluate the association of anaesthesia and surgery with postoperative headache in elective surgery patients By multiple logistic regression analysis of data collected during a six-month period from 446 patients undergoing elective surgery, a prospective single centre cohort study in a university hospital. Participants were interviewed preoperatively and for five days postoperatively regarding the appearance of headache; while demographics, life style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative adverse effects in elective surgery patients are recorded.
Read the detailed description
A dedicated team interviewed patients preoperatively and during the first five postoperative days and collected data regarding medical history, surgery, anaesthesia and the presence of postoperative headache by manual record review. The frequency of preoperative headache was assessed by asking the subjects on the appearance or not of headache within the last year. Additional information were obtained to distinguish migraine which was deemed present only when the participants reported two or more of the following specific symptoms supporting this diagnosis as proposed by the International Headache Society; episodic headache (4-72 hours) with the following features: moderate or severe throbbing pain, worsened by movement, associated with nausea/vomiting, photophobia or phonophobia, with or without visual aura.
Specifically, preoperative data included patients' demographics, marital status, life-style and habits, as caffeine consumption (>200 mg/day or >2 cups of coffee/day), alcohol (drink equivalent > 15ml absolute alcohol) and tobacco consumption, previous experience or/and family history of headache. Intraoperative data included the type of anaesthesia (general, regional anaesthesia or their combination); anaesthetic drugs used; type and duration of surgery; intraoperative patients' position; and intraoperative adverse events including hypotension (decrease >20% from baseline), hypertension (increase >20% from baseline), hypercarbia (PaCO2 >6 kPa) and hypoxia (SpO2 <90%). Noticeably, the choice of anaesthetic technique and postoperative management were determined by the engaged anaesthesiologist.
Postoperative headache was defined as a dichotomous variable (i.e. present or not present) by asking the participants twice daily for the first five days (or less if discharged earlier) after anaesthesia and surgery.
- Conditions
- Drug Withdrawal Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Postoperative Headache in Elective Surgery Patients
The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.
Measured: 6 months
Secondary outcomes (1)
Factors Associated With Postoperative Headache
Demographic, anaesthetic and surgical factors associated with postoperative headache
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug Withdrawal HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374346
- Sponsor's protocol ID
- 8/11/2004
- Status last verified
- Nov 2015
- First submitted
- 24 Feb 2015
- Last updated
- 1 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With the Presence of Postoperative Headache in Elective Surgery Patients: a Prospective Single Center Cohort Study
- ClinicalTrials.gov ID
- NCT02374346
- Acronym / sponsor ID
- 8/11/2004
- Conditions
- Drug Withdrawal Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 1 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the association of anaesthesia and surgery with postoperative headache in elective surgery patients By multiple logistic regression analysis of data collected during a six-month period from 446 patients undergoing elective surgery, a prospective single centre cohort study in a university hospital. Participants were interviewed preoperatively and for five days postoperatively regarding the appearance of headache; while demographics, life style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative adverse effects in elective surgery patients are recorded.
Detailed description
A dedicated team interviewed patients preoperatively and during the first five postoperative days and collected data regarding medical history, surgery, anaesthesia and the presence of postoperative headache by manual record review. The frequency of preoperative headache was assessed by asking the subjects on the appearance or not of headache within the last year. Additional information were obtained to distinguish migraine which was deemed present only when the participants reported two or more of the following specific symptoms supporting this diagnosis as proposed by the International Headache Society; episodic headache (4-72 hours) with the following features: moderate or severe throbbing pain, worsened by movement, associated with nausea/vomiting, photophobia or phonophobia, with or without visual aura.
Specifically, preoperative data included patients' demographics, marital status, life-style and habits, as caffeine consumption (>200 mg/day or >2 cups of coffee/day), alcohol (drink equivalent > 15ml absolute alcohol) and tobacco consumption, previous experience or/and family history of headache. Intraoperative data included the type of anaesthesia (general, regional anaesthesia or their combination); anaesthetic drugs used; type and duration of surgery; intraoperative patients' position; and intraoperative adverse events including hypotension (decrease >20% from baseline), hypertension (increase >20% from baseline), hypercarbia (PaCO2 >6 kPa) and hypoxia (SpO2 <90%). Noticeably, the choice of anaesthetic technique and postoperative management were determined by the engaged anaesthesiologist.
Postoperative headache was defined as a dichotomous variable (i.e. present or not present) by asking the participants twice daily for the first five days (or less if discharged earlier) after anaesthesia and surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures
Key inclusion criteria (1 listed)
- all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures
Key exclusion criteria (5 listed)
- patient refusal
- age under 18 years
- cognitive dysfunction
- head trauma or neurological disorders
- difficulty with language comprehension or any other inability to communicate verbally with the interviewer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Postoperative Headache in Elective Surgery Patients
Time frame: 6 months
The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.
1 secondary outcome
Factors Associated With Postoperative Headache
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Withdrawal Headache, run by Attikon Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Postoperative Headache in Elective Surgery Patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.