Propofol Adverse ReactionEarly Phase 1NCT05486819
Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection
A Early Phase 1 study testing Propofol Injection in people with Propofol Adverse Reaction, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Propofol Adverse Reaction
- What is being tested?
- Propofol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 2 Feb 2023
- Phase
- Early Phase 1
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years old.
- Patients classified as ASA I or II.
Who cannot join
- Patients with the history of allergy to propofol or lignocaine.
- Patients took any medication for analgesia or sedation in the past 24 hours.
- Body mass index (BMI) more than 30.
- Patients classified as ASA III \& IV.
- Severe mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lignocaine Versus Sodium Bicarbonate on Reducing Pain Due to Intravenous Injection of Propofol : a Prospective Randomised Double-blinded, Controlled Study
To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI).
Read the detailed description
Propofol is the most commonly used intravenous (IV) anesthetic drug for induction of anesthesia and for sedation. It is almost an ideal IV anesthetic agent, but pain which occur during its injection still remains a problem. This pain may not be a serious complication, but most patients remember it as an unpleasant encounter with anesthetists. In one survey, pain on propofol injection (POPI) stands 7th most important problem in the current practice of anesthesia . About 70 to 90% of patients who were given propofol for anesthesia induction experience pain during injection and this pain can be quite severe. All phenols irritate skin and mucous membranes. Thus, propofol being an alkyl-phenol is expected to induce pain despite the fact that it is almost isotonic. POPI has also been described as angialgia which means that the pain is due to vascular involvement . POPI is immediate as well as delayed after 10-20 seconds . The immediate pain is due to irritation of vein endothelium while as delayed pain is due to the release of mediators such a kininogen from kinin cascade . The most frequently used drug to alleviate POPI is intravenous lignocaine. The use of lignocaine to decrease POPI is due to its local anesthetic effect on the veins. However, it does not alleviate pain effectively in about 40% of the patients treated in this way (2). Administration of sodium bicarbonate was proved to reduce POPI. The proposed mechanism is through increasing sodium ions concentration as well as increasing serum pH through its buffering effect.
- Conditions
- Propofol Adverse Reaction
- Being tested
- Propofol Injection
- Keywords
- lignocaine,sodium bicarbonate,pain on propofol injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol InjectionDrug
adding lignocaine or sodium bicarbonate to propofol to reduce pain during injection
| Study group | Role | What they receive |
|---|---|---|
| Group (L) | Active comparator | receive 3 ml (60 mg) of lignocaine 2% added to propofol during injection Receives: Drug: Propofol Injection |
| Group (B) | Active comparator | receive 3 ml of sodium bicarbonate 8.5% added to propofol during injection Receives: Drug: Propofol Injection |
| Group (S) | Placebo comparator | receive 3 ml of normal saline added to propofol during injection Receives: Drug: Propofol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating
Measured: 5 months
Secondary outcomes (1)
1. Pain intensity at any top up doses of propofol. 2. Heart rate: baseline, 5 seconds, 1 minute & 5 minutes after injection. 3. Blood pressure: baseline, immediately after assessing the pain score then 5 minutes later
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Aug 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486819
- Sponsor's protocol ID
- Pain during propofol injection
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lignocaine Versus Sodium Bicarbonate on Reducing Pain Due to Intravenous Injection of Propofol : a Prospective Randomised Double-blinded, Controlled Study
- ClinicalTrials.gov ID
- NCT05486819
- Acronym / sponsor ID
- Pain during propofol injection
- Conditions
- Propofol Adverse Reaction
- Keywords
- lignocaine,sodium bicarbonate,pain on propofol injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 4 Aug 2022 (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.
To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI).
Detailed description
Propofol is the most commonly used intravenous (IV) anesthetic drug for induction of anesthesia and for sedation. It is almost an ideal IV anesthetic agent, but pain which occur during its injection still remains a problem. This pain may not be a serious complication, but most patients remember it as an unpleasant encounter with anesthetists. In one survey, pain on propofol injection (POPI) stands 7th most important problem in the current practice of anesthesia . About 70 to 90% of patients who were given propofol for anesthesia induction experience pain during injection and this pain can be quite severe. All phenols irritate skin and mucous membranes. Thus, propofol being an alkyl-phenol is expected to induce pain despite the fact that it is almost isotonic. POPI has also been described as angialgia which means that the pain is due to vascular involvement . POPI is immediate as well as delayed after 10-20 seconds . The immediate pain is due to irritation of vein endothelium while as delayed pain is due to the release of mediators such a kininogen from kinin cascade . The most frequently used drug to alleviate POPI is intravenous lignocaine. The use of lignocaine to decrease POPI is due to its local anesthetic effect on the veins. However, it does not alleviate pain effectively in about 40% of the patients treated in this way (2). Administration of sodium bicarbonate was proved to reduce POPI. The proposed mechanism is through increasing sodium ions concentration as well as increasing serum pH through its buffering effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (L) | Active comparator | Drug: Propofol Injectionreceive 3 ml (60 mg) of lignocaine 2% added to propofol during injection |
| Group (B) | Active comparator | Drug: Propofol Injectionreceive 3 ml of sodium bicarbonate 8.5% added to propofol during injection |
| Group (S) | Placebo comparator | Drug: Propofol Injectionreceive 3 ml of normal saline added to propofol during injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 65 years old.
- Patients classified as ASA I or II.
Key exclusion criteria (5 listed)
- Patients with the history of allergy to propofol or lignocaine.
- Patients took any medication for analgesia or sedation in the past 24 hours.
- Body mass index (BMI) more than 30.
- Patients classified as ASA III \& IV.
- Severe mental illness.
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 |
|---|---|---|
| Propofol Injectionadding lignocaine or sodium bicarbonate to propofol to reduce pain during injection | Drug | Group (B), Group (L), Group (S) |
Primary outcome
measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating
Time frame: 5 months
1 secondary outcome
1. Pain intensity at any top up doses of propofol. 2. Heart rate: baseline, 5 seconds, 1 minute & 5 minutes after injection. 3. Blood pressure: baseline, immediately after assessing the pain score then 5 minutes later
Time frame: 5 months
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 5 Sep 2024.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Propofol Injection in people with Propofol Adverse Reaction, run by Cairo 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 5 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 5 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating (time frame: 5 months). 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 5 Sep 2024.