Sedation for Fiberoptic Bronchoscopy: Fewer Adverse Cardiovascular Effects with Propofol than with Midazolam

Öztürk, Tülin; Çakan, Alpaslan; Gülerçe, G.; Olgac, Guven; Deren, Serpil; Özsöz, Ayşe

doi:10.1055/s-2004-825919

Cited by 15 publications

(5 citation statements)

References 24 publications

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“…A total of 172 (64.4%) patients experienced 286 AEs, with 71 (52.6%) patients in the HSK3486 group and 101 (76.5%) in the propofol group. There was no grade 3 or above AEs in the HSK3486 group, and most were self-curing or self-limited, findings similar to other anesthetics/sedatives [ 27 , 28 , 33 ]. The types of AEs and drug-related AEs were similar in both the HSK3486 and propofol groups.…”

Section: Discussionmentioning

confidence: 57%

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Luo

Zhang

et al. 2022

CNS Drugs

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Background Fiberoptic bronchoscopy is a complex procedure with the need for sufficient patient anesthesia/sedation while maintaining safety. This trial aimed to evaluate the efficacy, safety, and pharmacokinetics of HSK3486 during fiberoptic bronchoscopy. Methods This multicenter, double-blind, randomized, non-inferiority, parallel-group phase 3 trial was conducted in patients who underwent fiberoptic bronchoscopy. Patients randomly received HSK3486 0.4 mg/kg (N = 134) or propofol 2.0 mg/kg (N = 133). The primary efficacy endpoint was the successful rate of fiberoptic bronchoscopy, and secondary efficacy endpoints included successful induction of anesthesia/sedation, duration, time to being fully alert, and time to patient discharge. Safety assessments and drug concentrations were also measured. Results A total of 267 patients completed fiberoptic bronchoscopy, with a success rate of 100% and a 95% confidence interval of − 2.8 to 2.8% for the difference between the groups, which met the predesigned criteria of > − 8%, confirming the noninferiority of anesthesia/sedation produced by HSK3486 compared to propofol. Among the secondary efficacy endpoints, only time to full alertness (median 8.50 vs. 6.00 min, P = 0.012) and time to discharge (median 13.00 vs. 9.87 min, P = 0.002) were slightly longer in the HSK3486 group. The incidence of adverse events was significant lower in the HSK3486 group (52.6 vs. 76.5%, P < 0.001) mainly because of less pain on injection (4.4 vs. 39.4%, P < 0.001) compared to the propofol group. HSK3486 had a similar terminal elimination half-life as propofol. Conclusions HSK3486 exhibited non-inferiority anesthesia/sedation compared to propofol in patients undergoing fiberoptic bronchoscopy, and had a good safety profile with a lower incidence of pain on injection. Trial Registration Clinicaltrials.gov, NCT04111159, registered on

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Section: Discussionmentioning

confidence: 57%

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Luo

Zhang

et al. 2022

CNS Drugs

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“…Three studies are removed because of the study design and 4 RCTs are ultimately included in the meta-analysis. [ 13 , 26 – 28 ]…”

Section: Resultsmentioning

confidence: 99%

“…The detail methods of propofol and midazolam for bronchoscopy are summarized in Table 1 . Among the 4 RCTs, 3 studies report the recovery time, [ 13 , 26 , 27 ] 4 studies report the operation time, [ 13 , 26 , 27 , 28 ] 3 studies report the induction time, [ 13 , 26 , 27 ] 2 studies report the lowest SpO 2 , [ 26 , 28 ] 3 studies report the SpO2 < 90%, [ 26 – 28 ] and 2 studies report the major arhythmias. [ 26 , 28 ] Jadad scores of the 4 eligible studies vary from 3 to 4, and thus, this quality assessment confirms these studies with high quality.…”

Section: Resultsmentioning

confidence: 99%

The comparison of propofol and midazolam for bronchoscopy

Wang

Dai

2018

Medicine

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Background:Propofol and midazolam are widely used for the sedation of bronchoscopy. This systematic review and meta-analysis is conducted to compare the efficacy of propofol and midazolam for bronchoscopy.Methods:The databases including PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases are systematically searched for collecting the randomized controlled trials (RCTs) regarding the efficacy of propofol and midazolam for bronchoscopy.Results:This meta-analysis has included 4 RCTs. Compared with midazolam intervention in patients undergoing bronchoscopy, propofol intervention is associated with remarkably reduced recovery time [standard mean difference (SMD) = −0.74; 95% confidence interval (95% CI) = −1.04 to −0.45; P < .00001], but demonstrates no significant impact on operation time (SMD = −0.01; 95% CI = −0.16 to 0.13; P = .87), induction time (SMD = −0.58; 95% CI = −1.19 to 0.03; P = .06), lowest oxyhemoglobin saturation (SpO2, SMD = 0.24; 95% CI = −0.09 to 0.58; P = .15), SpO2 <90% [risk ratio (RR) = 1.02; 95% CI = 0.82–1.25; P = .88), and major arrhythmias (RR = 0.56; 95% CI = 0.26–1.19; P = .13).Conclusion:Propofol sedation is able to reduce recovery time and shows similar safety compared with midazolam sedation during bronchoscopy.

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“…These findings coincide with the study done by various authors in their respective studies. [ 4 9 10 ]…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of propofol versus midazolam in fiberoptic endotracheal intubation

et al. 2016

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Background:Fiberoptic intubation is a technique commonly used for difficult airways. Conscious sedation is desirable to make this procedure tolerable, and it is essential that patients are cooperative, relaxed, and comfortable especially when difficult airway anatomy or pathology is encountered.Objective:To compare the safety and efficacy of propofol versus midazolam in oral fiberoptic endotracheal intubation in terms of hemodynamic changes, level of sedation, ease of intubation, and patient comfort and complications.Materials and Methods:In a prospective randomized study, 60 patients of age group 18–60 years and American Society of Anesthesiologists health classification of I and II with anticipated difficult intubation were randomly allocated into two groups. Both the groups were premedicated with injection glycopyrrolate 0.005 mg/kg and injection butorphanol 1 mg and nebulized with 4 ml of 4% lignocaine starting 20 min before the surgery. After that patients in Group I received intravenous propofol 1–2 mg/kg to a maximum of 2 mg/kg followed by 20 mg increments if needed and Group II received 0.05 mg/kg midazolam followed by 2 mg increments till the adequate level of sedation was reached. Patients were monitored for hemodynamic parameters, sedation according to observer's assessment of alertness score, intubation score, intubation time, patient comfort, satisfaction score, and complications, if any. Results were statistically analyzed.Results:The mean sedation score, patient comfort score, and patient satisfaction were greater in propofol group (P < 0.05) but there were no significant differences in hemodynamics, intubating conditions, and complications.Conclusion:We conclude that compared with midazolam, propofol provides better sedation for fiberoptic endotracheal intubation and better patient comfort and satisfaction.

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Sedation for Fiberoptic Bronchoscopy: Fewer Adverse Cardiovascular Effects with Propofol than with Midazolam

Cited by 15 publications

References 24 publications

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

The comparison of propofol and midazolam for bronchoscopy

Efficacy and safety of propofol versus midazolam in fiberoptic endotracheal intubation

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