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The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain

The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04078087
Enrollment
90
Registered
2019-09-04
Start date
2020-02-01
Completion date
2020-07-07
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Site Coldness, Propofol Adverse Reaction

Keywords

Body mass index, Follicular phase, Injection pain, Luteal phase, Menopause, Menstrual cycle, Visual analogue scale

Brief summary

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

Detailed description

* Study population Ninety patients, 18 years - 65yor older, physical status ASA I&II, scheduled to undergo elective gynecological surgery, will be enrolled in this prospective observational study. * Patients' recruitment Patients will be recruited after admission to the hospital, same day they scheduled for surgery. All women who will meet inclusion criteria and gave written informed consent for participation in the study will be enrolled. 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.

Interventions

DRUGNon obese

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).

DRUGObese.

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).

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 years - 65yor older, * physical status ASA I&II

Exclusion criteria

* irregular menstrual cycle, * those who received hormonal therapy for any cause, * on oral contraceptive pills, * breast feeding, * pregnant, * history of total abdominal hysterectomy and/or bilateral salphingo-opherectomy. * patients who had difficulty in understanding the visual analogue scale (VAS)/ pain scoring systems, * renal or hepatic insufficiency, * anticipated difficult tracheal intubation, and * hypersensitivity to the study drugs. * Also, patients on antidepressants and analgesics

Design outcomes

Primary

MeasureTime frameDescription
VAS scoreimmediately after injectionIncidence & 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).

Secondary

MeasureTime frameDescription
Type of Propofol injection pain, early or late (after 10 seconds)after 10 secondsType of Propofol injection pain, early or late (after 10 seconds)
Hemodynamic variablestill 5 minutes after tracheal intubationHemodynamic variables were recorded before administration of the IV anesthetic, as well as after TI and 5 minutes later
Rate pressure productstill 5 minutes after tracheal intubationRate pressure products were calculated (an indicator of the heart's demand for oxygen) at same hemodynamic predetermined measuring timings.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026