The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain
Condition: Injection Site Coldness; Propofol Adverse Reaction
Study type: Observational

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.
    

Intervention name(s): Non obese; Obese.
Intervention type(s): Drug; Drug
Intervention description(s): 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).; 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).
Other intervention name(s): Group NO; Group O
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18 years - 65yor older, physical status ASA I&II, scheduled to undergo elective surgery,
        were enrolled in this prospective observational study
      
Keywords: Body mass index; Follicular phase; Injection pain; Luteal phase; Menopause; Menstrual cycle; Visual analogue scale