Hypothermia
Conditions
Brief summary
To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane
Detailed description
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.
Interventions
DRUGSelection of anesthetic induction technique
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Core Temperature | intraoperative | Core temperature at 15 minute intervals |
| Temperature Below 36.0 Degrees C | Intraoperative | Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Blood Pressure | intraoperative | Blood pressure decrease after intravenous anesthetic induction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| 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 | 52 |
| 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 | 51 |
| 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 | 51 |
| 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 | 52 |
| 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 | 52 |
| Total | 309 |
Baseline characteristics
| Characteristic | Sevoflurane in 100% Oxygen, Age >55 | Sevoflurane in 50% Nitrous, Age >55 | Total | Sevoflurane in 100% Oxygen, Age <56 | Sevoflurane in 50% Nitrous, Age <56 | Propofol, Age <56 | Propofol With Phenylephrine, Age <56 |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 27 Participants | 58 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 25 Participants | 251 Participants | 51 Participants | 52 Participants | 51 Participants | 51 Participants |
| Age, Continuous | 68.2 years STANDARD_DEVIATION 8.4 | 66.2 years STANDARD_DEVIATION 7.4 | 50.0 years STANDARD_DEVIATION 15.3 | 42.8 years STANDARD_DEVIATION 10.1 | 43.0 years STANDARD_DEVIATION 8.8 | 39.0 years STANDARD_DEVIATION 11.2 | 40.6 years STANDARD_DEVIATION 9.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 52 participants | 52 participants | 309 participants | 51 participants | 52 participants | 51 participants | 51 participants |
| Sex: Female, Male Female | 19 Participants | 25 Participants | 153 Participants | 30 Participants | 20 Participants | 30 Participants | 29 Participants |
| Sex: Female, Male Male | 33 Participants | 27 Participants | 156 Participants | 21 Participants | 32 Participants | 21 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 52 | 0 / 51 | 0 / 51 | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 | 0 / 51 | 0 / 51 | 0 / 52 | 0 / 52 |
Outcome results
Primary
Measurement of Core Temperature
Core temperature at 15 minute intervals
Time frame: intraoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sevoflurane in 100% Oxygen, Age <56 | Measurement of Core Temperature | 15 minute temperature | 36.42 degree C | Standard Deviation 0.49 |
| Sevoflurane in 100% Oxygen, Age <56 | Measurement of Core Temperature | 30 minute temperature | 36.41 degree C | Standard Deviation 0.49 |
| Sevoflurane in 100% Oxygen, Age <56 | Measurement of Core Temperature | 45 minute temperature | 36.47 degree C | Standard Deviation 0.53 |
| Sevoflurane in 100% Oxygen, Age <56 | Measurement of Core Temperature | 60 minute temperature | 36.52 degree C | Standard Deviation 0.56 |
| Sevoflurane in 50% Nitrous, Age <56 | Measurement of Core Temperature | 45 minute temperature | 36.50 degree C | Standard Deviation 0.43 |
| Sevoflurane in 50% Nitrous, Age <56 | Measurement of Core Temperature | 30 minute temperature | 36.48 degree C | Standard Deviation 0.44 |
| Sevoflurane in 50% Nitrous, Age <56 | Measurement of Core Temperature | 15 minute temperature | 36.44 degree C | Standard Deviation 0.44 |
| Sevoflurane in 50% Nitrous, Age <56 | Measurement of Core Temperature | 60 minute temperature | 36.57 degree C | Standard Deviation 0.42 |
| Propofol, Age <56 | Measurement of Core Temperature | 60 minute temperature | 36.03 degree C | Standard Deviation 0.53 |
| Propofol, Age <56 | Measurement of Core Temperature | 45 minute temperature | 36.00 degree C | Standard Deviation 0.45 |
| Propofol, Age <56 | Measurement of Core Temperature | 30 minute temperature | 35.95 degree C | Standard Deviation 0.41 |
| Propofol, Age <56 | Measurement of Core Temperature | 15 minute temperature | 35.96 degree C | Standard Deviation 0.4 |
| Propofol With Phenylephrine, Age <56 | Measurement of Core Temperature | 15 minute temperature | 36.35 degree C | Standard Deviation 0.38 |
| Propofol With Phenylephrine, Age <56 | Measurement of Core Temperature | 60 minute temperature | 36.51 degree C | Standard Deviation 0.43 |
| Propofol With Phenylephrine, Age <56 | Measurement of Core Temperature | 30 minute temperature | 36.36 degree C | Standard Deviation 0.4 |
| Propofol With Phenylephrine, Age <56 | Measurement of Core Temperature | 45 minute temperature | 36.45 degree C | Standard Deviation 0.4 |
| Sevoflurane in 100% Oxygen, Age >55 | Measurement of Core Temperature | 45 minute temperature | 36.29 degree C | Standard Deviation 0.5 |
| Sevoflurane in 100% Oxygen, Age >55 | Measurement of Core Temperature | 60 minute temperature | 36.34 degree C | Standard Deviation 0.51 |
| Sevoflurane in 100% Oxygen, Age >55 | Measurement of Core Temperature | 30 minute temperature | 36.31 degree C | Standard Deviation 0.48 |
| Sevoflurane in 100% Oxygen, Age >55 | Measurement of Core Temperature | 15 minute temperature | 36.34 degree C | Standard Deviation 0.46 |
| Sevoflurane in 50% Nitrous, Age >55 | Measurement of Core Temperature | 30 minute temperature | 36.38 degree C | Standard Deviation 0.53 |
| Sevoflurane in 50% Nitrous, Age >55 | Measurement of Core Temperature | 45 minute temperature | 36.41 degree C | Standard Deviation 0.57 |
| Sevoflurane in 50% Nitrous, Age >55 | Measurement of Core Temperature | 60 minute temperature | 36.44 degree C | Standard Deviation 0.55 |
| Sevoflurane in 50% Nitrous, Age >55 | Measurement of Core Temperature | 15 minute temperature | 36.41 degree C | Standard Deviation 0.52 |
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
Time frame: Intraoperative
Population: Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sevoflurane in 100% Oxygen, Age <56 | Temperature Below 36.0 Degrees C | 8 Percentage |
| Sevoflurane in 50% Nitrous, Age <56 | Temperature Below 36.0 Degrees C | 8 Percentage |
| Propofol, Age <56 | Temperature Below 36.0 Degrees C | 30 Percentage |
| Propofol With Phenylephrine, Age <56 | Temperature Below 36.0 Degrees C | 8 Percentage |
| Sevoflurane in 100% Oxygen, Age >55 | Temperature Below 36.0 Degrees C | 14 Percentage |
| Sevoflurane in 50% Nitrous, Age >55 | Temperature Below 36.0 Degrees C | 14 Percentage |
Secondary
Measurement of Blood Pressure
Blood pressure decrease after intravenous anesthetic induction
Time frame: intraoperative
Population: Percentage of patients whose blood pressure decreased after propofol administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sevoflurane in 100% Oxygen, Age <56 | Measurement of Blood Pressure | 49 percentage of patients |
| Sevoflurane in 50% Nitrous, Age <56 | Measurement of Blood Pressure | 29 percentage of patients |