Pain Due to Propofol InjectionPhase 1/2NCT01186549

The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain and Hemodynamic Changes Due to Propofol Injection

A Phase 1/2 study testing Ephedrine 30microgram/kg, lidocaine0.5mg/kg -ephedrine30 micrograms/kg and ephedrine 70 microgram/kg in people with Pain Due to Propofol Injection and Hemodynamic Changes Due to Propofol Injection, run by Qazvin University Of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objectives: Injection pain and hypotension are two main adverse effects of propofol which distresses patient. The aim of this prospective double blind study was to compare the effect of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and hemodynamic changes due to propofol induction. Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Pain Due to Propofol Injection, Hemodynamic Changes Due to Propofol Injection
What is being tested?: Ephedrine 30microgram/kg, lidocaine0.5mg/kg -ephedrine30 micrograms/kg and ephedrine 70 microgram/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 1 siteIran
Study dates: Aug 2010to Nov 2010
Phase: Phase 1/2
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

patients with American Society of Anesthesiologists(ASA)physical statusIandII

Who cannot join

patients with difficulty in communication
history of allergic, neurologic or cardiovascular disease
patients who had received an analgesic medication within 24 hr before surgery

Trial locations and contacts

1 site in 1 country.

Iran1 site

Qazvin university of medical science
Qazvin, Qazvin Province, 34197/59811

Other trials in Iran

About this study

Official title: Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia

Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30), ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate were recorded before induction, just before intubation, and one minute after intubation

Conditions: Pain Due to Propofol Injection, Hemodynamic Changes Due to Propofol Injection
Being tested: Ephedrine 30microgram/kg, lidocaine0.5mg/kg -ephedrine30 micrograms/kg, ephedrine 70 microgram/kg, lidocaine 0.5mg/kg, normal saline 2ml
Keywords: propofol, ephedrine, pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ephedrine 30microgram/kgDrug
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
lidocaine0.5mg/kg -ephedrine30 micrograms/kgDrug
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
ephedrine 70 microgram/kgDrug
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
lidocaine 0.5mg/kgDrug
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
normal saline 2mlDrug
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected

Study groups in NCT01186549
Study group	Role	What they receive
ephedrine 30 microgram/kg	Active comparator	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected Receives: Drug: Ephedrine 30microgram/kg
ephedrine 70 microgram/kg	Active comparator	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected Receives: Drug: ephedrine 70 microgram/kg
lidocaine0.5mg/kg -ephedrine30 micrograms/kg	Active comparator	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected Receives: Drug: lidocaine0.5mg/kg -ephedrine30 micrograms/kg
lidocaine 0.5mg/kg	Active comparator	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected Receives: Drug: lidocaine 0.5mg/kg
normal saline 2ml	Placebo comparator	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected Receives: Drug: normal saline 2ml

What is being measured

The primary outcome is the main question the study is designed to answer.

pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)
Measured: during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness

Secondary outcomes (2)

mean arterial blood pressure
mean arterial blood pressure is assessed by nonivasive automatic blood pressure measurement
Measured: before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation
heart rate
is assessed by echocardiogram monitoring
Measured: before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Nov 2010

First posted23 Aug 2010 (estimated)
Study startAug 2010
Primary completionOct 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain Due to Propofol InjectionStudies of the same condition, open and under way.
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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01186549
Sponsor's protocol ID: ACTRN12610000610033
Other IDs: ACTRN12610000610033
Status last verified: Oct 2012
First submitted: 19 Aug 2010
Last updated: 11 Oct 2012
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia
ClinicalTrials.gov ID: NCT01186549
Acronym / sponsor ID: ACTRN12610000610033
Conditions: Pain Due to Propofol Injection, Hemodynamic Changes Due to Propofol Injection
Keywords: propofol, ephedrine, pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Qazvin University Of Medical SciencesUniversity, hospital or other
Study start: Aug 2010
Primary completion: Oct 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 23 Aug 2010 (estimated)
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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
ephedrine 30 microgram/kg	Active comparator	Drug: Ephedrine 30microgram/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
ephedrine 70 microgram/kg	Active comparator	Drug: ephedrine 70 microgram/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
lidocaine0.5mg/kg -ephedrine30 micrograms/kg	Active comparator	Drug: lidocaine0.5mg/kg -ephedrine30 micrograms/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
lidocaine 0.5mg/kg	Active comparator	Drug: lidocaine 0.5mg/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
normal saline 2ml	Placebo comparator	Drug: normal saline 2mlPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

patients with American Society of Anesthesiologists(ASA)physical statusIandII

Key exclusion criteria (3 listed)

patients with difficulty in communication
history of allergic, neurologic or cardiovascular disease
patients who had received an analgesic medication within 24 hr before surgery

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
Ephedrine 30microgram/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected	Drug	ephedrine 30 microgram/kg
lidocaine0.5mg/kg -ephedrine30 micrograms/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected	Drug	lidocaine0.5mg/kg -ephedrine30 micrograms/kg
ephedrine 70 microgram/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected	Drug	ephedrine 70 microgram/kg
lidocaine 0.5mg/kgPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected	Drug	lidocaine 0.5mg/kg
normal saline 2mlPatients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected	Drug	normal saline 2ml

Primary outcome

pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)
Time frame: during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness

2 secondary outcomes

mean arterial blood pressure
Time frame: before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation
heart rate
Time frame: before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after 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 11 Oct 2012.

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?

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 3 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 11 Oct 2012. 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 Iran. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS) (time frame: during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01186549.

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 11 Oct 2012.