Injection Site ColdnessNCT04078087
The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain
An observational study of Injection Site Coldness and Propofol Adverse Reaction, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injection Site Coldness, Propofol Adverse Reaction
- What is being tested?
- Non obese and Obese.
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 7 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 years - 65yor older, physical status ASA I\&II, scheduled to undergo elective surgery, were enrolled in this prospective observational study
Who may be able to join
- 18 years - 65yor older,
- physical status ASA I\&II
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Injection Site Coldness, Propofol Adverse Reaction
- Being tested
- Non obese, Obese.
- Keywords
- Body mass index, Follicular phase, Injection pain, Luteal phase, Menopause, Menstrual cycle, Visual analogue scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non obeseDrug
Also called Group NO
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).
Obese.Drug
Also called Group O
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).
| Study group | Role | What they receive |
|---|---|---|
| Non obese | Non obese (whether normal weight or overweight) = Group "NO" Receives: Drug: Non obese | |
| Obese | obese = Group "O" Receives: Drug: Obese. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: immediately after injection
Secondary outcomes (3)
Type of Propofol injection pain, early or late (after 10 seconds)
Type of Propofol injection pain, early or late (after 10 seconds)
Measured: after 10 seconds
Hemodynamic variables
Hemodynamic variables were recorded before administration of the IV anesthetic, as well as after TI and 5 minutes later
Measured: till 5 minutes after tracheal intubation
Rate pressure products
Rate pressure products were calculated (an indicator of the heart's demand for oxygen) at same hemodynamic predetermined measuring timings.
Measured: till 5 minutes after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Feb 2020
- Primary completion30 Jun 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site ColdnessStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raham Hasan Mostafa, MD, Ain Shams University
- Investigators
- Raham H Mostafa, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078087
- Sponsor's protocol ID
- R43/2019
- Other IDs
- R43/2019
- Status last verified
- Oct 2020
- First submitted
- 2 Sep 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Excel Sheet, individual deidentified participant data will be shared study protocol, statistical analysis plan will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Mass Index In Relation To Menstrual Cycle Phase on Propofol Injection Pain
- ClinicalTrials.gov ID
- NCT04078087
- Acronym / sponsor ID
- R43/2019
- Conditions
- Injection Site Coldness, Propofol Adverse Reaction
- Keywords
- Body mass index, Follicular phase, Injection pain, Luteal phase, Menopause, Menstrual cycle, Visual analogue scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non obese | – | Drug: Non obeseNon obese (whether normal weight or overweight) = Group "NO" |
| Obese | – | Drug: Obese.obese = Group "O" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years - 65yor older, physical status ASA I\&II, scheduled to undergo elective surgery, were enrolled in this prospective observational study
Key inclusion criteria (2 listed)
- 18 years - 65yor older,
- physical status ASA I\&II
Key exclusion criteria (11 listed)
- irregular menstrual cycle,
- those who received hormonal therapy for any cause,
- on oral contraceptive pills,
- breast feeding,
- pregnant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non obeseAlso: Group NOAfter 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). | Drug | Non obese |
| Obese.Also: Group OAfter 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). | Drug | Obese |
Primary outcome
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).
3 secondary outcomes
Type of Propofol injection pain, early or late (after 10 seconds)
Time frame: after 10 seconds
Hemodynamic variables
Time frame: till 5 minutes after tracheal intubation
Rate pressure products
Time frame: till 5 minutes after tracheal intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: Undecided. Excel Sheet, individual deidentified participant data will be shared study protocol, statistical analysis plan will be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raham H Mostafa, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injection Site Coldness and Propofol Adverse Reaction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: immediately after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.