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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04078087

Collaborator

(none)

Enrollment

Location

5.2

Actual Duration (Months)

17.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Injection Site Coldness Propofol Adverse Reaction	Drug: Non obese Drug: Obese.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jul 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Non obese Non obese (whether normal weight or overweight) = Group "NO"	Drug: Non 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). Other Names: Group NO
Obese obese = Group "O"	Drug: 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). Other Names: Group O

Arm

Intervention/Treatment

Non obese

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

Drug: Non 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).

Other Names:

Group NO

Obese

obese = Group "O"

Drug: Obese.

Other Names:

Group O

Outcome Measures

Primary Outcome Measures

VAS score [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 Outcome Measures

Type of Propofol injection pain, early or late (after 10 seconds) [after 10 seconds]
Type of Propofol injection pain, early or late (after 10 seconds)
Hemodynamic variables [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
Rate pressure products [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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