Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced PainPhase 2No acronymNCT05886972
Effect Of Patient Awareness About Possibility Of Occurrence Of Pain During Propofol Injection On The Rate Of Incidence And Severity Of Pain During Injection .
A Phase 2 study testing Awareness about propofol injection induced pain in people with Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced Pain, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration. However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced Pain
- What is being tested?
- Awareness about propofol injection induced pain
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Nov 2023
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients aged 20 to 40 years of The American Society of Anesthesiologists (ASA) I-II , who will be undergoing elective surgery under general anesthesia
Who cannot join
- patient with mental illness, poor understanding or difficulty in communication or pain assessment .
- any organ dysfunction, neurological disease, diabetes mellitus .
- patient with high education level (patient with education level after high secondary school) .
- patient with Body Mass Index (BMI) < 18 or > 30
- allergy to the study drugs .
- history of chronic pain or those taking regular analgesics, anti-inflammatory drugs pre-operatively .
- history of drug abuse and other contraindication for lidocaine such as severe bradycardia, Wolf-Parkinson-White syndrome, and other tachyarrhythmias .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Patient Awareness About Possibility Of Occurrence Of Pain During Propofol Injection On The Rate Of Incidence And Severity Of Pain During Injection ; A Randomized Controlled Study.
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration.
However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .
Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.
Read the detailed description
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration .
However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .
The mechanism of propofol injection pain has not been known yet, but many factors are involved that include the intrinsic drug property (e.g. emulsion composition, pH of the formulation, temperature, injection volume and osmolarity) .
As the lipid solvent irritates the venous intima and triggers a local kallikrein kinin cascade by discharging bradykinin and inflammatory factors, and injection pain occurs when peripheral nerve endings are directly exposed to propofol .
Other factors, including the site of injection, speed of injection, vein size, blood buffering, sex and simultaneous use of different drugs, seem to affect the incidence and severity of propofol injection pain .
The incidence and the severity of pain following propofol injection is increased in peripheral site of injection , smaller size of the vessels and slow injection and the pain can be reduced by rapid injection of propofol into the large sized veins as veins of antecubital fossa, however, this is not always practical in clinical practice .
Propofol injection pain is more common and more sever in females than males and the suggested reason of gender difference is due to the mechanical effect that male has a larger venous size than female while another factor suggested is the difference of pain sensitivity observed between the gender.
Low education level also increases the incidence and the severity of propofol injection pain as high education level will help during the patients' preoperative preparations and will reduce preoperative anxiety .
Psychogenic factors such as anxiety, depression, and fear of pain are frequently observed in patients undergoing elective surgery. Among these, preoperative anxiety and pain sensitivity has been the most important factors .
Preoperative anxiety activates the release of neuroendocrine mediators related to stress response and negatively affects anesthetic methods, surgical recovery, and postoperative pain levels .
Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.
Many approaches have been recommended to decrease propofol injection pain including both pharmacological (e.g. pre-treatment with Paracetamol , lidocaine, magnesium sulfate, ketamine , ondansetron , Granisetron ,and and triglycerides ) .
It is generally approved that lidocaine is an adequate anesthetic that precludes injection pain. However, its adverse cardiovascular and hemodynamic effects and swelling at its injection site require to be further studied .
- Being tested
- Awareness about propofol injection induced pain
- Keywords
- Propofol injection induced pain, Patient awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness about propofol injection induced painBehavioural
The aim of the study is to observe the effect of patient awareness about the possibility of occurrence of pain during propofol injection on the rate of incidence and severity of pain during injection as a primary goal as the pain score of propofol injection pain is the main end point of the study .
| Study group | Role | What they receive |
|---|---|---|
| Patients aware about propofol injection induced pain | Active comparator | Patients who will be informed about the possibility of incidence of propofol injection pain Receives: Behavioral: Awareness about propofol injection induced pain |
| Patients not aware about propofol injection induced pain | Active comparator | Patients will not be informed about the possibility of incidence of propofol injection pain Receives: Behavioral: Awareness about propofol injection induced pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain intensity will be measured by Verbal categorical scoring (VCS) Verbal categorical scoring (VCS) is a 4-point pain scale: 0-no pain, 1-mild pain with no behavioral sign, 2-moderate pain accompanied by a behavioral sign, and 3-severe pain with a strong vocal response accompanied by facial grimacing, arm withdrawal, or crying ( Jeon Y ,2012).
Measured: During first 10 seconds after receiving first dose of propofol
Secondary outcomes (2)
Age
Age per years
Measured: Preoperative visit
Weight
Weight by kilograms
Measured: Preoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced PainStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups One informed about possibilities of pain with injection Other group not informed
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hussein Bahr, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886972
- Sponsor's protocol ID
- FMBSUREC/02052023/sayem
- Acronym
- No acronym
- Status last verified
- Jul 2026
- First submitted
- 24 May 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Patient Awareness About Possibility Of Occurrence Of Pain During Propofol Injection On The Rate Of Incidence And Severity Of Pain During Injection ; A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05886972
- Acronym / sponsor ID
- No acronym / FMBSUREC/02052023/sayem
- Keywords
- Propofol injection induced pain, Patient awareness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 2 Jun 2023 (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.
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration.
However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .
Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.
Detailed description
Propofol is the most common intravenous (IV) anesthetic agent, used for anesthesia induction and maintenance during surgeries due to its rapid onset and short duration .
However, the incidence of propofol injection pain occurs in about 20% to 90% of patients that can decrease patient satisfaction and safety .
The mechanism of propofol injection pain has not been known yet, but many factors are involved that include the intrinsic drug property (e.g. emulsion composition, pH of the formulation, temperature, injection volume and osmolarity) .
As the lipid solvent irritates the venous intima and triggers a local kallikrein kinin cascade by discharging bradykinin and inflammatory factors, and injection pain occurs when peripheral nerve endings are directly exposed to propofol .
Other factors, including the site of injection, speed of injection, vein size, blood buffering, sex and simultaneous use of different drugs, seem to affect the incidence and severity of propofol injection pain .
The incidence and the severity of pain following propofol injection is increased in peripheral site of injection , smaller size of the vessels and slow injection and the pain can be reduced by rapid injection of propofol into the large sized veins as veins of antecubital fossa, however, this is not always practical in clinical practice .
Propofol injection pain is more common and more sever in females than males and the suggested reason of gender difference is due to the mechanical effect that male has a larger venous size than female while another factor suggested is the difference of pain sensitivity observed between the gender.
Low education level also increases the incidence and the severity of propofol injection pain as high education level will help during the patients' preoperative preparations and will reduce preoperative anxiety .
Psychogenic factors such as anxiety, depression, and fear of pain are frequently observed in patients undergoing elective surgery. Among these, preoperative anxiety and pain sensitivity has been the most important factors .
Preoperative anxiety activates the release of neuroendocrine mediators related to stress response and negatively affects anesthetic methods, surgical recovery, and postoperative pain levels .
Awareness of patient about propofol injection pain can affect patient anxiety and stress that will be reflected on incidence and severity of occurance of propofol injection pain. In our study the effect of patient awareness on propofol injection pain will be evaluated after adequate using of the pharmacological and non-pharmacological therapy that have been demonstrated to be effective in attenuating injection pain.
Many approaches have been recommended to decrease propofol injection pain including both pharmacological (e.g. pre-treatment with Paracetamol , lidocaine, magnesium sulfate, ketamine , ondansetron , Granisetron ,and and triglycerides ) .
It is generally approved that lidocaine is an adequate anesthetic that precludes injection pain. However, its adverse cardiovascular and hemodynamic effects and swelling at its injection site require to be further studied .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups One informed about possibilities of pain with injection Other group not informed
| Arm | Type | Receives |
|---|---|---|
| Patients aware about propofol injection induced pain | Active comparator | Behavioral: Awareness about propofol injection induced painPatients who will be informed about the possibility of incidence of propofol injection pain |
| Patients not aware about propofol injection induced pain | Active comparator | Behavioral: Awareness about propofol injection induced painPatients will not be informed about the possibility of incidence of propofol injection pain |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients aged 20 to 40 years of The American Society of Anesthesiologists (ASA) I-II , who will be undergoing elective surgery under general anesthesia
Key exclusion criteria (7 listed)
- patient with mental illness, poor understanding or difficulty in communication or pain assessment .
- any organ dysfunction, neurological disease, diabetes mellitus .
- patient with high education level (patient with education level after high secondary school) .
- patient with Body Mass Index (BMI) < 18 or > 30
- allergy to the study drugs .
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 |
|---|---|---|
| Awareness about propofol injection induced painThe aim of the study is to observe the effect of patient awareness about the possibility of occurrence of pain during propofol injection on the rate of incidence and severity of pain during injection as a primary goal as the pain score of propofol injection pain is the main end point of the study . | Behavioural | Patients aware about propofol injection induced pain, Patients not aware about propofol injection induced pain |
Primary outcome
Pain assessment
Time frame: During first 10 seconds after receiving first dose of propofol
Pain intensity will be measured by Verbal categorical scoring (VCS) Verbal categorical scoring (VCS) is a 4-point pain scale: 0-no pain, 1-mild pain with no behavioral sign, 2-moderate pain accompanied by a behavioral sign, and 3-severe pain with a strong vocal response accompanied by facial grimacing, arm withdrawal, or crying ( Jeon Y ,2012).
2 secondary outcomes
Age
Time frame: Preoperative visit
Weight
Time frame: Preoperative visit
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided. Not decided yet
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Awareness about propofol injection induced pain in people with Effect of Patient Awareness on Incidence and Severity of Propofol Injection Induced Pain, run by Beni-Suef 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 1 inclusion and 7 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 27 Jul 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain assessment (time frame: During first 10 seconds after receiving first dose of propofol). 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 27 Jul 2026.