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

NCT04078087 | Completed

• 1 other identifier: R43/2019
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Injection Site Coldness; Propofol Adverse Reaction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  after 10 seconds

• Hemodynamic variables

  till 5 minutes after tracheal intubation

• Rate pressure products

  till 5 minutes after tracheal intubation

Study Arms (2)

Non obese

Non obese (whether normal weight or overweight) = Group "NO"

Drug: Non obese

Obese

obese = Group "O"

Drug: Obese.

Interventions

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).

Also known as: Group NO

Non obese

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).

Also known as: Group O

Obese

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years - 65yor older,
• physical status ASA I\&II

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Adiposity; O-antigen, Acinetobacter strain 90

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Officials

• Raham H Mostafa, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 4, 2019
• Study Start: February 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 7, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

EG (1)