Trial Outcomes & Findings for Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery. (NCT NCT01214057)
NCT ID: NCT01214057
Last Updated: 2021-11-01
Results Overview
Blood loss was determined by subtracting the volume of irrigation used intraoperatively from the total volume of fluid in the collection canisters.The Neptune Waste Management System will be used for this purpose. This is a closed suction system that digitally counts the amount of fluid suctioned.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)
Results posted on
2021-11-01
Participant Flow
Participant milestones
| Measure |
Total Intravenous Anesthesia
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 16.2 • n=12 Participants
|
50.3 years
STANDARD_DEVIATION 16 • n=11 Participants
|
50.8 years
STANDARD_DEVIATION 16.1 • n=23 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
10 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
13 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)Blood loss was determined by subtracting the volume of irrigation used intraoperatively from the total volume of fluid in the collection canisters.The Neptune Waste Management System will be used for this purpose. This is a closed suction system that digitally counts the amount of fluid suctioned.
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Volume of Blood Loss
|
152.9 milliliters (mL)
Standard Deviation 161.3
|
355.9 milliliters (mL)
Standard Deviation 393.4
|
PRIMARY outcome
Timeframe: during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)Surgeons rated the surgical field using the Boezaart score (which ranges from 0 to 5, with 5 indicating the most compromised surgical field), and this outcome measure reports the number of participants with a Boezaart score of 5. Boezaart scoring is as follows: 0 (No bleeding, cadaveric conditions); 1 (Slight bleeding, no suctioning required), 2 (Slight bleeding, occasional suctioning required; 3 (Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed); 4 (Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed); 5 (Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Number of Participants for Whom Surgical Field Visualization Was Deemed Severely Compromised
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baselineThromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function.
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
TEG MA [maximum clot strength]
|
71.2 millimeters (mm)
Standard Deviation 4.80
|
62.3 millimeters (mm)
Standard Deviation 11.91
|
|
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
adenosine diphosphate channel (ADP) MA [maximum contribution of ADP to clot strength]
|
58.2 millimeters (mm)
Standard Deviation 10.84
|
42.8 millimeters (mm)
Standard Deviation 12.07
|
|
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
arachidonic acid channel (AA) MA [maximum contribution of AA to clot strength]
|
60.5 millimeters (mm)
Standard Deviation 15.01
|
50.6 millimeters (mm)
Standard Deviation 14.64
|
PRIMARY outcome
Timeframe: During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)Thromboelastography-Platelet Mapping will be performed to assess the effect of the anesthetics on platelet function. Data are reported as Maximum Amplitude (MA) in millimeters (mm). A greater MA value indicates stronger clotting and greater platelet function.
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
adenosine diphosphate channel (ADP) MA [maximum contribution of ADP to clot strength]
|
51.7 millimeters (mm)
Standard Deviation 15.58
|
55.1 millimeters (mm)
Standard Deviation 9.20
|
|
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
TEG MA [maximum clot strength]
|
71.9 millimeters (mm)
Standard Deviation 5.66
|
68.7 millimeters (mm)
Standard Deviation 7.88
|
|
Platelet Function as Assessed by Thromboelastography (TEG) Platelet Mapping (PM)
arachidonic acid channel (AA) MA [maximum contribution of AA to clot strength]
|
57.7 millimeters (mm)
Standard Deviation 19.28
|
57.1 millimeters (mm)
Standard Deviation 16.32
|
PRIMARY outcome
Timeframe: 0-5 minutes after induction of anesthesiaThe Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--more negative optical density unit values indicate greater nasal blood flow and less light.
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System
|
0.02 optical density units
Standard Deviation 0.18237
|
-0.05 optical density units
Standard Deviation 0.13739
|
PRIMARY outcome
Timeframe: 60-90 minutes after induction of anesthesiaThe Rhinolux system was used to measure nasal blood flow (it assessed changes in the swelling of the nasal mucosa by a tissue light absorption technique similar to that used in pulse oximetry)--negative values indicate greater nasal blood flow and less light.
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Nasal Blood Flow to the Sinonasal Mucosa as Assessed by the Rhinolux System
|
-0.11 optical density units
Standard Deviation 0.30615
|
-0.41 optical density units
Standard Deviation 0.2583
|
SECONDARY outcome
Timeframe: during the surgery (from the moment of injection of local anesthetic in the nasal cavity to the end of application of local hemostatis agents, about 1 to 5 hours)Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Duration of Surgery
|
2.4 hours
Standard Deviation 1.2
|
3.6 hours
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)Population: These data were not collected for 1 participant in the Inhaled anesthesia arm.
The VAS ranged from 1-10, with 1 being no pain and 10 being worst pain.
Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=10 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Quality of Recovery as Indicated by Pain Rating Using a Visual Analogue Scale (VAS)
|
3.4 units on a scale
Standard Deviation 3.3
|
5.3 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Quality of Recovery as Indicated by Number of Participants With Nausea
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Quality of Recovery as Indicated by Recovery Time in the PACU
|
67 minutes
Standard Deviation 30.41
|
69 minutes
Standard Deviation 27.04
|
SECONDARY outcome
Timeframe: During time in post-anesthesia care unit (PACU) (about 30 minutes to 1.5 hours)Outcome measures
| Measure |
Total Intravenous Anesthesia
n=12 Participants
Total Intravenous Anesthesia (TIVA) with propofol and remifentanyl
Propofol and Remifentanyl: Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
|
Inhaled Anesthesia
n=11 Participants
Inhaled anesthesia with sevoflurane and remifentanyl.
Sevoflurane and Remifentanyl: Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
|
|---|---|---|
|
Quality of Recovery as Indicated by Number of Participants Who Received an Analgesic Post-operatively
morphine
|
2 Participants
|
4 Participants
|
|
Quality of Recovery as Indicated by Number of Participants Who Received an Analgesic Post-operatively
hydromorphone
|
3 Participants
|
1 Participants
|
|
Quality of Recovery as Indicated by Number of Participants Who Received an Analgesic Post-operatively
midazolam
|
1 Participants
|
1 Participants
|
|
Quality of Recovery as Indicated by Number of Participants Who Received an Analgesic Post-operatively
meperidine
|
2 Participants
|
0 Participants
|
Adverse Events
Total Intravenous Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inhaled Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Davide Cattano, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place