Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Postoperative Headache in Elective Surgery Patients | The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Factors Associated With Postoperative Headache | Demographic, anaesthetic and surgical factors associated with postoperative headache | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Elective Surgery Patients | A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total number of 446 adult patients admitted for elective surgery were included in the study.
Exclusion criteria: 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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Elective Surgery Patients | All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Postoperative Headache in Elective Surgery Patients | The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample. | Frequency of postoperative headache in total sample (n=446)," "Post-op Headache, no History of Headache (n=229)," "Post-op Headache, History of Headache (n=217), where n= number of participants analyzed" | Posted | Number | participants | 6 months |
|
|
Not provided
Serious and Other [non-serious] adverse events were not collected/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elective Surgery Patients | A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| P. Matsota | Attikon Hospital | 00302105831000 | matsota@yahoo.gr |
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Factors Associated With Postoperative Headache | Demographic, anaesthetic and surgical factors associated with postoperative headache | Posted | Number | participants | 6 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| intraoperative hypotension |
|
| smoking |
|
| caffeine consumption |
|
| Smoking as a factor for developing postoperative headache | t-test, 2 sided | 0.006 | Odds Ratio (OR) | 1.85 | 2-Sided | 95 | 1.19 | 2.84 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |
| Intraoperative hypotension associated with postoperative headache in total sample | t-test, 2 sided | 0.008 | Odds Ratio (OR) | 2.11 | 2-Sided | 95 | 1.22 | 3.66 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |
| Female gender as a factor for developing postoperative headache | t-test, 2 sided | 0.024 | Odds Ratio (OR) | 1.85 | 2-Sided | 95 | 1.08 | 3.15 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |
| Association of female gender and postoperative headache | t-test, 2 sided | 0.005 | Odds Ratio (OR) | 4.56 | 2-Sided | 95 | 1.58 | 13.17 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |
| Association of intraoperative hypotension and postoperative headache | t-test, 2 sided | 0.006 | Odds Ratio (OR) | 3.79 | 2-Sided | 95 | 1.48 | 9.72 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |
| Association of caffeine consumption and postoperative headache | t-test, 2 sided | 0.041 | Odds Ratio (OR) | 3.86 | 2-Sided | 95 | 1.06 | 14.06 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |
| Association of sevoflurane administration and postoperative headache | t-test, 2 sided | 0.001 | Odds Ratio (OR) | 4.26 | 2-Sided | 95 | 1.82 | 9.95 | Yes | Non-Inferiority or Equivalence | Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors. |