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| ID | Type | Description | Link |
|---|---|---|---|
| R43/2019 | Registry Identifier | Ain Shams research ethical committee |
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There are suggestions from experimental pain studies that pain perception in patients with severe obesity differs compared with individuals with lower BMI values, with a tendency for patients with severe obesity to be hypoalgesic - that is, to have reduced numerical pain scores to a variety of painful stimuli. That finding could be related to: associated reduced cognitive function (complex attention, verbal and visual memory, and decision making) in severe obesity.
The purpose of this study is to determine differences between females' pain levels whether they are obese or non-obese, during different menstrual phases (premenstrual, postmenstrual and menopausal phases) through propofol injection pain given for induction of GA
Patients will be divided into 2 groups according to BMI levels: Non obese (whether normal weight or overweight) = Group "NO" and obese = Group "O". Normal weight is defined as BMI 18.5-24.9, overweight as BMI 25.0-29.9 and obesity as BMI ≥ 30. [8] This study is a single blind study, where patients are aware of their menstrual status but supporting examiner is not aware of the patients' menstrual status.
Patients will be instructed on a vertical VAS 0-10 cm where (0) is marked as no pain and (10) is marked as the worst pain ever felt After standard anesthesia monitoring, Administration of oxygen will be performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose will be injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients will be observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset will be documented (to differentiate early or late type of pain).
Another anesthesiologist, who is unaware of the study groups, will assess the intensity of pain after propofol injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non obese | Non obese (whether normal weight or overweight) = Group "NO" |
| |
| Obese | obese = Group "O" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non obese | Drug | After standard anesthesia monitoring, Administration of oxygen was performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose was injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients were observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset was documented (to differentiate early or late type of pain). |
| Measure | Description | Time Frame |
|---|---|---|
| VAS score | Incidence & severity of propofol injection pain (Mild pain was defined as VAS score 0-3, Moderate as VAS score 4-6, Severe as VAS score 7-10). | immediately after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Propofol injection pain, early or late (after 10 seconds) | Type of Propofol injection pain, early or late (after 10 seconds) | after 10 seconds |
| Hemodynamic variables | Hemodynamic variables were recorded before administration of the IV anesthetic, as well as after TI and 5 minutes later |
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Inclusion Criteria:
Exclusion Criteria:
Females only
18 years - 65yor older, physical status ASA I&II, scheduled to undergo elective surgery, were enrolled in this prospective observational study
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| Name | Affiliation | Role |
|---|---|---|
| Raham H Mostafa, MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Egypt |
Excel Sheet, individual deidentified participant data will be shared study protocol, statistical analysis plan will be shared
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| ID | Term |
|---|---|
| D050154 | Adiposity |
| C106365 | O-antigen, Acinetobacter strain 90 |
| ID | Term |
|---|---|
| D050218 | Body Fat Distribution |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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| Obese. | Drug | After standard anesthesia monitoring, Administration of oxygen was performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose was injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients were observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset was documented (to differentiate early or late type of pain). |
|
|
| till 5 minutes after tracheal intubation |
| Rate pressure products | Rate pressure products were calculated (an indicator of the heart's demand for oxygen) at same hemodynamic predetermined measuring timings. | till 5 minutes after tracheal intubation |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001823 | Body Composition |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D010829 | Physiological Phenomena |