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NCT Number: NCT04078087

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

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

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Key information

Conditions

Injection Site Coldness Propofol Adverse Reaction

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams University Hospitals

Cairo, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Group NO

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).

Other names: Group O

Primary outcomes

  1. VAS score

    Time frame: immediately after injection

    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).

Secondary outcomes

  1. Type of Propofol injection pain, early or late (after 10 seconds)

    Time frame: after 10 seconds

    Type of Propofol injection pain, early or late (after 10 seconds)

  2. Hemodynamic variables

    Time frame: till 5 minutes after tracheal intubation

    Hemodynamic variables were recorded before administration of the IV anesthetic, as well as after TI and 5 minutes later

  3. Rate pressure products

    Time frame: till 5 minutes after tracheal intubation

    Rate pressure products were calculated (an indicator of the heart's demand for oxygen) at same hemodynamic predetermined measuring timings.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2019
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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