Injection Site IrritationValsalvaNCT05225610
Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper GIT Endoscopy
A study testing Valsalva Manoeuvre, Dexmedetomidine Injection [Precedex] and normal Saline in people with Injection Site Irritation, run by Tanta University at 1 site in Saudi Arabia.
Trial summary
No previous study has cited the use of the Valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. Therefore, investigators plan a study to evaluate the analgesic efficacy of the Valsalva manoeuvre in alleviating pain during propofol injection as compared to… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation
- What is being tested?
- Valsalva Manoeuvre, Dexmedetomidine Injection [Precedex] and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 19 Feb 2022to 10 Sep 2022
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged 30-60 years old.
- American Society of Anesthesiologist physical status(ASA) Grade I and II.
- Upper gastrointestinal Endoscopies.
Who cannot join
- Patients with mental illness, restlessness.
- Cardio-respiratory disease.
- Chronic pain disorder.
- Use of preoperative analgesic medication.
- History of propofol allergy.
- History of drug abuse.
- Inability to perform the Valsalva manoeuvre. -
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Sharurah Armed Forces Hospital
Sharurah, Najran Region, 000000
About this study
Official title: Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study
No previous study has cited the use of the Valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. Therefore, investigators plan a study to evaluate the analgesic efficacy of the Valsalva manoeuvre in alleviating pain during propofol injection as compared to dexmedetomidine injection.
Read the detailed description
Propofol is a commonly used anaesthetic for inducing general anaesthesia. Pain on propofol injection is distressing and is one of the limitations of its use. Propofol is a phenol compound, which irritates nerve endings on the venous endothelium to produce immediate pain, whereas delayed pain is mediated by the release of bradykinin. Bradykinin causes vasodilation and increases venous permeability, thereby facilitating contact of the aqueous phase of propofol with nerve endings. Delayed pain occurs 10-20 seconds after injection.
Various methods have been tried so far to reduce pain on propofol injection. A commonly used technique is lignocaine either as pre-treatment or mixed with propofol. Other methods include the use of butorphanol, ondansetron, metoclopramide, opioid, or thiopentone. Propofol injection into a large vein, pre-injection cooling, or warming of propofol have also been investigated.
The Valsalva manoeuvre is a physiological technique, used in the reduction of pain associated with several procedures. The Valsalva manoeuvre alleviates both the somatic and psychological aspects of painful procedures.
Dexmedetomidine is an alpha-2 adrenoceptor agonist that has analgesic and sedative properties, it has been evaluated for reducing the incidence and intensity of propofol-induced pain, but reported results are inconsistent.
in this study, investigators will study the effect of Valsalva manoeuvre as compared with dexmedetomidine injection in reducing the pain associated with propofol injection in upper gastrointestinal endoscopies.
- Conditions
- Injection Site Irritation
- Being tested
- Valsalva Manoeuvre, Dexmedetomidine Injection [Precedex], normal Saline
- Keywords
- Propofol injection pain, Dexmedetomidine, Valsalva Maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva ManoeuvreOther
Blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds
Dexmedetomidine Injection [Precedex]Drug
Also called Precedex
The study drugs will be kept at room temperature, preservative-free and will be prepared by an independent anaesthetist into 5 ml of total volume with the addition of 0.9 % normal saline. Tourniquet will be left inflated for 1 minute. Dexmedetomidine mixture and saline will be injected over 5 seconds. After the injection of the drugs, the tourniquet will be released
normal SalineDrug
Also called saline
5 ml saline will be administered.
| Study group | Role | What they receive |
|---|---|---|
| VALSALVA Group | Experimental | 40 Patients will perform the Valsalva manoeuvre before starting propofol injection by blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds and 5 ml saline will be administered in 5 seconds. Receives: Other: Valsalva Manoeuvre |
| DEXMED Group | Experimental | 40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group, patients will receive 0.5 µg/kg Dexmedetomidine diluted in 5 ml saline in 5 seconds as a sedating dose prior to injection of propofol. Receives: Drug: Dexmedetomidine Injection [Precedex] |
| CONTROL Group | Placebo comparator | 40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group and only 5 ml saline will be administered over 5 seconds. Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
using a ruler as the visual analogue scale(VAS), The VAS score ranged from 0-10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Patients will be instructed to mark a point on the VAS ruler that represented the intensity of pain. The pain score was determined by measuring the distance in mm between 0 (no pain) and the mark will be indicated by the patient on the ruler.
Measured: 20 seconds after propofol injection.
Secondary outcomes (4)
Withdrawal response score
withdrawal response will be assessed using standard questions including comfort during injection, verbal response, and behavioural signs (facial grimacing, arm withdrawal, or tears). the withdrawal response scoring will be graded on a 4-point scale: 0 = no pain, 1 = mild pain (pain reported only in response to questioning without any behavioural signs), 2 = moderate pain (pain reported in response to questioning and accompanied by behavioural signs or pain reported spontaneously without questioning), and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).
Measured: 20 seconds after propofol injection
Heart Rate(HR) beat / minute
the heart rate (HR) will be recorded before the Valsalva manoeuvre, at 1 minute, at 2 minutes after the manoeuvre, following propofol injection, and 5 minutes later on
Measured: 10 minutes
Propofol injection site reaction
the propofol injection site will be checked for signs of inflammation including oedema, pain, wheal, and flare
Measured: 24 hour
Non-invasive blood pressure(NIBP) mmHg
Non-invasive blood pressure(NIBP) will be recorded before the Valsalva manoeuvre, at 1 minute, 2 minutes after the manoeuvre, following propofol injection, and 5 minutes later on.
Measured: 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start19 Feb 2022
- Primary completion15 Apr 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED ABDELAZIZ SHAMA, Tanta University
- Investigators
- AHMED A SHAMA, MD, Principal investigator, LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225610
- Sponsor's protocol ID
- IRC13412/02/9
- Acronym
- Valsalva
- Status last verified
- Oct 2022
- First submitted
- 1 Feb 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05225610
- Acronym / sponsor ID
- Valsalva / IRC13412/02/9
- Conditions
- Injection Site Irritation
- Keywords
- Propofol injection pain, Dexmedetomidine, Valsalva Maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Feb 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 4 Feb 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.
No previous study has cited the use of the Valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. Therefore, investigators plan a study to evaluate the analgesic efficacy of the Valsalva manoeuvre in alleviating pain during propofol injection as compared to dexmedetomidine injection.
Detailed description
Propofol is a commonly used anaesthetic for inducing general anaesthesia. Pain on propofol injection is distressing and is one of the limitations of its use. Propofol is a phenol compound, which irritates nerve endings on the venous endothelium to produce immediate pain, whereas delayed pain is mediated by the release of bradykinin. Bradykinin causes vasodilation and increases venous permeability, thereby facilitating contact of the aqueous phase of propofol with nerve endings. Delayed pain occurs 10-20 seconds after injection.
Various methods have been tried so far to reduce pain on propofol injection. A commonly used technique is lignocaine either as pre-treatment or mixed with propofol. Other methods include the use of butorphanol, ondansetron, metoclopramide, opioid, or thiopentone. Propofol injection into a large vein, pre-injection cooling, or warming of propofol have also been investigated.
The Valsalva manoeuvre is a physiological technique, used in the reduction of pain associated with several procedures. The Valsalva manoeuvre alleviates both the somatic and psychological aspects of painful procedures.
Dexmedetomidine is an alpha-2 adrenoceptor agonist that has analgesic and sedative properties, it has been evaluated for reducing the incidence and intensity of propofol-induced pain, but reported results are inconsistent.
in this study, investigators will study the effect of Valsalva manoeuvre as compared with dexmedetomidine injection in reducing the pain associated with propofol injection in upper gastrointestinal endoscopies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VALSALVA Group | Experimental | Other: Valsalva Manoeuvre40 Patients will perform the Valsalva manoeuvre before starting propofol injection by blowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds and 5 ml saline will be administered in 5 seconds. |
| DEXMED Group | Experimental | Drug: Dexmedetomidine Injection [Precedex]40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group, patients will receive 0.5 µg/kg Dexmedetomidine diluted in 5 ml saline in 5 seconds as a sedating dose prior to injection of propofol. |
| CONTROL Group | Placebo comparator | Drug: normal Saline40 patients will receive the tube between the lips, however, the manoeuvre will not be performed in this group and only 5 ml saline will be administered over 5 seconds. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged 30-60 years old.
- American Society of Anesthesiologist physical status(ASA) Grade I and II.
- Upper gastrointestinal Endoscopies.
Key exclusion criteria (7 listed)
- Patients with mental illness, restlessness.
- Cardio-respiratory disease.
- Chronic pain disorder.
- Use of preoperative analgesic medication.
- History of propofol allergy.
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 |
|---|---|---|
| Valsalva ManoeuvreBlowing into rubber tubing connected to a sphygmomanometer and raising the mercury column to 30 mmHg for at least 20 seconds | Other | VALSALVA Group |
| Dexmedetomidine Injection [Precedex]Also: PrecedexThe study drugs will be kept at room temperature, preservative-free and will be prepared by an independent anaesthetist into 5 ml of total volume with the addition of 0.9 % normal saline. Tourniquet will be left inflated for 1 minute. Dexmedetomidine mixture and saline will be injected over 5 seconds. After the injection of the drugs, the tourniquet will be released | Drug | DEXMED Group |
| normal SalineAlso: saline5 ml saline will be administered. | Drug | CONTROL Group |
Primary outcome
Pain Assessment
Time frame: 20 seconds after propofol injection.
using a ruler as the visual analogue scale(VAS), The VAS score ranged from 0-10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Patients will be instructed to mark a point on the VAS ruler that represented the intensity of pain. The pain score was determined by measuring the distance in mm between 0 (no pain) and the mark will be indicated by the patient on the ruler.
4 secondary outcomes
Withdrawal response score
Time frame: 20 seconds after propofol injection
Heart Rate(HR) beat / minute
Time frame: 10 minutes
Propofol injection site reaction
Time frame: 24 hour
Non-invasive blood pressure(NIBP) mmHg
Time frame: 10 minutes.
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 20 Oct 2022.
- Individual participant dataSharing planned: No
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.
AHMED A SHAMA, MD principal investigator
LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsalva Manoeuvre, Dexmedetomidine Injection [Precedex] and normal Saline in people with Injection Site Irritation, run by Tanta University at 1 site in Saudi Arabia.
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 3 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 20 Oct 2022. 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 Saudi Arabia. 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.
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: 20 seconds after propofol 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 20 Oct 2022.