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To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane
Hypothermia occurs with anesthetic induction due to redistribution hypothermia. Hypothermia has adverse effects and should be avoided or minimized. Intravenous propofol induction is the most common technique used for anesthetic induction. There is preliminary evidence that there is less redistribution hypothermia when anesthetic induction is achieved by inhalation induction compared to intravenous induction. There is not enough data to compel a change in practice patterns. This study will enroll a larger number of patients in order to provide stronger evidence that there is a significant difference between induction techniques on body temperature. Patients will be randomly assigned to two variation of inhalation induction techniques and two variations of intravenous induction. The effect on temperature between the four groups will be compared. Reducing the degree of hypothermia has the potential to decrease surgical infection rate as well as providing other benefits to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sevoflurane in 100% oxygen, age <56 | Active Comparator | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. |
|
| sevoflurane in 50% nitrous, age <56 | Active Comparator | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. |
|
| propofol, age <56 | Active Comparator | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. |
|
| propofol with phenylephrine, age <56 | Active Comparator | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. |
|
| sevoflurane in 100% oxygen, age >55 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selection of anesthetic induction technique | Drug | Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Core Temperature | Core temperature at 15 minute intervals | intraoperative |
| Temperature Below 36.0 Degrees C | Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Blood Pressure | Blood pressure decrease after intravenous anesthetic induction | intraoperative |
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Inclusion Criteria:
Elective surgery Adult, age >= 18 years old Scheduled for general anesthesia Medically fit and able to safely go any of the four anesthetic inductions in the study
Exclusion Criteria:
Emergency surgery, or any other aspiration risk Minor, age <18 Pregnant Febrile illness Contraindication to nasal instrumentation Allergy to propofol Malignant hyperthermia Requiring Total Invravenous Anesthesia (TIVA) Inability to oxygenate on less than 50% FiO2 Intra-cranial surgery Receiving vasoactive medications Significant valvular heart disease Unstable cardiac disease Surgery requiring prone or lateral positioning Contraindication to nitrous oxide Prisoners
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan V Roth, MD | Albert Einstein Healthcare Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert EinsteinMedical Center | Philadelphia | Pennsylvania | 19141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31694576 | Derived | Roth JV, Braitman LE, Hunt LH. Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study. BMC Anesthesiol. 2019 Nov 6;19(1):203. doi: 10.1186/s12871-019-0866-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sevoflurane in 100% Oxygen, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| FG001 | Sevoflurane in 50% Nitrous, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| FG002 | Propofol, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| FG003 | Propofol With Phenylephrine, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| FG004 | Sevoflurane in 100% Oxygen, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| FG005 | Sevoflurane in 50% Nitrous, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sevoflurane in 100% Oxygen, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Core Temperature | Core temperature at 15 minute intervals | Posted | Mean | Standard Deviation | degree C | intraoperative |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sevoflurane in 100% Oxygen, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Roth, M.D. | Albert Einstein Healthcare Network | 2154567979 | rothj@einstein.edu |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.
|
| sevoflurane in 50% nitrous, age >55 | Active Comparator | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55. |
|
|
| BG001 | Sevoflurane in 50% Nitrous, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| BG002 | Propofol, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| BG003 | Propofol With Phenylephrine, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| BG004 | Sevoflurane in 100% Oxygen, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| BG005 | Sevoflurane in 50% Nitrous, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Propofol, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| OG003 | Propofol With Phenylephrine, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| OG004 | Sevoflurane in 100% Oxygen, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
| OG005 | Sevoflurane in 50% Nitrous, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes |
|
|
| Primary | Temperature Below 36.0 Degrees C | Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia | Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia | Posted | Number | Percentage | Intraoperative |
|
|
|
| Secondary | Measurement of Blood Pressure | Blood pressure decrease after intravenous anesthetic induction | Percentage of patients whose blood pressure decreased after propofol administration | Posted | Number | percentage of patients | intraoperative |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Sevoflurane in 50% Nitrous, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes | 0 | 52 | 0 | 52 |
| EG002 | Propofol, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes | 0 | 51 | 0 | 51 |
| EG003 | Propofol With Phenylephrine, Age <56 | The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes | 0 | 51 | 0 | 51 |
| EG004 | Sevoflurane in 100% Oxygen, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes | 0 | 52 | 0 | 52 |
| EG005 | Sevoflurane in 50% Nitrous, Age >55 | The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes | 0 | 52 | 0 | 52 |
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| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|