Anesthesia
Conditions
Keywords
Anesthesia, Induction, Pain
Brief summary
The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia. Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Detailed description
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
Interventions
DRUGPropofol
Propofol (drug), intravenous, induction of anesthesia
DRUGPropofol 1%
Propofol (drug), intravenous, induction of anesthesia
Sponsors
B. Braun Melsungen AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female adults, age ≥ 18 years and ≤ 80 years * Anesthetic risk classified as ASA I-III * Patients undergoing elective surgery under general anesthesia * Signed informed consent
Exclusion criteria
* Simultaneous participation in another trial * Known or suspected drug abuse * Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication * Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics) * Patients taking lipid lowering drugs * History of decompensated renal failure * History of severe hepatic dysfunction, hepatic cirrhosis * Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia * History of convulsive disorders * Decompensated cardiac insufficiency * Hypovolemia * Increased intracranial pressure * Pregnancy (positive ß-HCG test) and lactation * Emergency situation * Patient who receives parenteral fat emulsion, e.g. intralipid * Patients incapable of giving consent personally * Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Expression of Pain During Injection | during first propofol bolus |
Secondary
| Measure | Time frame |
|---|---|
| Further Assessment of Injection Pain | during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia |
Countries
Germany
Participant flow
Recruitment details
First patient in: 07.05.2008 Last patient out: 24.09.2008
Participants by arm
| Arm | Count |
|---|---|
| Modified Propofol Modified propofol (Propofol 0.5%) | 50 |
| Propofol 1% Propofol 1% | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Propofol 1% | Modified Propofol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 34 Participants | 68 Participants |
| Age Continuous | 55.2 years STANDARD_DEVIATION 13.9 | 54.4 years STANDARD_DEVIATION 14.6 | 54.8 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment Germany | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Male | 35 Participants | 39 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 50 | 26 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Incidence of Expression of Pain During Injection
Time frame: during first propofol bolus
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Propofol | Incidence of Expression of Pain During Injection | 1 participants |
| Propofol 1% | Incidence of Expression of Pain During Injection | 7 participants |
Secondary
Further Assessment of Injection Pain
Time frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia