The Potential Regimen of Target-Controlled Infusion of Propofol in Flexible Bronchoscopy Sedation

A Randomized Controlled Trial

Ting Yu Lin, Yu Lun Lo, Chung Hsing Hsieh, Yung Lun Ni, Tsai Yu Wang, Horng Chyuan Lin, Chun Hua Wang, Chih Teng Yu, Han Pin Kuo

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Objectives:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.Methods:After alfentanil bolus, initial induction Ce of propofol was targeted at 2 μg/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 μg/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.Results:The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 μg/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p = 0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 μg/ml, p = 0.005) and the Ce of procedures was higher at 0.5 μg/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 μg/ml, p = 0.006). The adjustment frequency tended to be higher for titration at 0.1 μg/ml but was not statistically significant (2 (0~6) vs. 3 (0~6) vs. 3 (0~11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p = 0.001; 0 vs. 24.1%, p = 0.008, respectively).Conclusion:Titration at 0.5 μg/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.Trial Registration:ClinicalTrials.gov NCT01101477.

Original languageEnglish
Article numbere62744
JournalPLoS One
Volume8
Issue number4
DOIs
Publication statusPublished - Apr 24 2013
Externally publishedYes

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bronchoscopy
sedation
Bronchoscopy
Propofol
Titration
Randomized Controlled Trials
titration
hypoxia
hypotension
Alfentanil
Recovery
Hypotension
Oxyhemoglobins
Pharmacokinetics
dosage
Brain
Vital Signs
pharmacokinetics
Pharmaceutical Preparations
brain

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

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The Potential Regimen of Target-Controlled Infusion of Propofol in Flexible Bronchoscopy Sedation : A Randomized Controlled Trial. / Lin, Ting Yu; Lo, Yu Lun; Hsieh, Chung Hsing; Ni, Yung Lun; Wang, Tsai Yu; Lin, Horng Chyuan; Wang, Chun Hua; Yu, Chih Teng; Kuo, Han Pin.

In: PLoS One, Vol. 8, No. 4, e62744, 24.04.2013.

Research output: Contribution to journalArticle

Lin, Ting Yu ; Lo, Yu Lun ; Hsieh, Chung Hsing ; Ni, Yung Lun ; Wang, Tsai Yu ; Lin, Horng Chyuan ; Wang, Chun Hua ; Yu, Chih Teng ; Kuo, Han Pin. / The Potential Regimen of Target-Controlled Infusion of Propofol in Flexible Bronchoscopy Sedation : A Randomized Controlled Trial. In: PLoS One. 2013 ; Vol. 8, No. 4.
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abstract = "Objectives:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.Methods:After alfentanil bolus, initial induction Ce of propofol was targeted at 2 μg/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 μg/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.Results:The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70{\%}) in the group titrated at 0.5 μg/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3{\%}, p = 0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 μg/ml, p = 0.005) and the Ce of procedures was higher at 0.5 μg/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 μg/ml, p = 0.006). The adjustment frequency tended to be higher for titration at 0.1 μg/ml but was not statistically significant (2 (0~6) vs. 3 (0~6) vs. 3 (0~11)). Subgroup analysis revealed 14{\%} of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9{\%}, p = 0.001; 0 vs. 24.1{\%}, p = 0.008, respectively).Conclusion:Titration at 0.5 μg/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.Trial Registration:ClinicalTrials.gov NCT01101477.",
author = "Lin, {Ting Yu} and Lo, {Yu Lun} and Hsieh, {Chung Hsing} and Ni, {Yung Lun} and Wang, {Tsai Yu} and Lin, {Horng Chyuan} and Wang, {Chun Hua} and Yu, {Chih Teng} and Kuo, {Han Pin}",
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T1 - The Potential Regimen of Target-Controlled Infusion of Propofol in Flexible Bronchoscopy Sedation

T2 - A Randomized Controlled Trial

AU - Lin, Ting Yu

AU - Lo, Yu Lun

AU - Hsieh, Chung Hsing

AU - Ni, Yung Lun

AU - Wang, Tsai Yu

AU - Lin, Horng Chyuan

AU - Wang, Chun Hua

AU - Yu, Chih Teng

AU - Kuo, Han Pin

PY - 2013/4/24

Y1 - 2013/4/24

N2 - Objectives:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.Methods:After alfentanil bolus, initial induction Ce of propofol was targeted at 2 μg/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 μg/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.Results:The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 μg/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p = 0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 μg/ml, p = 0.005) and the Ce of procedures was higher at 0.5 μg/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 μg/ml, p = 0.006). The adjustment frequency tended to be higher for titration at 0.1 μg/ml but was not statistically significant (2 (0~6) vs. 3 (0~6) vs. 3 (0~11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p = 0.001; 0 vs. 24.1%, p = 0.008, respectively).Conclusion:Titration at 0.5 μg/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.Trial Registration:ClinicalTrials.gov NCT01101477.

AB - Objectives:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.Methods:After alfentanil bolus, initial induction Ce of propofol was targeted at 2 μg/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 μg/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.Results:The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 μg/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p = 0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 μg/ml, p = 0.005) and the Ce of procedures was higher at 0.5 μg/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 μg/ml, p = 0.006). The adjustment frequency tended to be higher for titration at 0.1 μg/ml but was not statistically significant (2 (0~6) vs. 3 (0~6) vs. 3 (0~11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p = 0.001; 0 vs. 24.1%, p = 0.008, respectively).Conclusion:Titration at 0.5 μg/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.Trial Registration:ClinicalTrials.gov NCT01101477.

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