Propofol-fentanyl versus propofol-dexmedetomidine in outpatient procedures sedation: a triple-blind, randomized controlled clinical trial
Propofol-fentanil versus propofol-dexmedetomidina na sedação para procedimentos ambulatoriais: ensaio clínico randomizado controlado triplo-cego
Nicole Morem Pilau Moritz, Getúlio Rodrigues de Oliveira Filho, José Eduardo Moritz, Jefferson Luiz Traebert
Abstract
Introduction
The choice of anesthetic agents plays a crucial role in procedural success. This study aimed to compare the effects of propofol-fentanyl and propofol-dexmedetomidine combinations, focusing on patient and surgeon perspectives in outpatient procedures.
Methods
A randomized, controlled, triple-blind clinical trial including 128 adult patients undergoing elective outpatient surgical procedures with sedation and local anesthesia. Patients were randomized to receive either propofol-fentanyl (PF, n = 64) or propofol-dexmedetomidine (PDex, n = 64). Primary outcomes were patient satisfaction, assessed using the ISAS-Br score, and the adequacy of sedation, evaluated by the surgeon and measured by a Numerical Rating Scale (NRS) for movement. Respiratory and hemodynamic changes, as well as awakening from anesthesia, adverse events during recovery, and time to hospital discharge were compared.
Results
No difference between patient satisfaction scores (median ISAS-Br [IQR]: PF 2.64 [2.45‒3.00] vs. PDex 3.00 [2.45‒3.00], p = 0.252). The PF group had a significantly lower
movement score (median NRS [IQR]: 0.5 [0.00‒2.25] vs. 2.0 [0.00‒5.00], p = 0.006). The incidence of intraoperative events related to respiration and hemodynamics, as postoperative pain and postoperative nausea/vomiting were similar. A higher proportion of patients sedated with PF awoke in the operating room (75% vs. 35.9%, p < 0.001), and 98.4% of the PF group vs. 92.2% of the PDex group were ready for hospital discharge in less than thirty minutes, p = 0.208.
Conclusion
Single doses of fentanyl or dexmedetomidine combined with propofol resulted in equivalent patient satisfaction, safety, and discharge times. The propofol-fentanyl combination
demonstrated superior sedation adequacy from the surgeon’s perspective and facilitated a faster emergence from anesthesia.
Keywords
Resumo
Introdução
A escolha dos agentes anestésicos desempenha um papel crucial no sucesso dos procedimentos. Este estudo teve como objetivo comparar os efeitos das combinações propofol-fentanil e propofol-dexmedetomidina, com foco nas perspectivas do paciente e do cirurgião em procedimentos ambulatoriais.
Métodos
Ensaio clínico randomizado, controlado e triplo-cego, incluindo 128 pacientes adultos submetidos a procedimentos cirúrgicos ambulatoriais eletivos com sedação e anestesia local. Os pacientes foram randomizados para receber propofol-fentanil (PF, n = 64) ou propofol-dexmedetomidina (PDex, n = 64). Os desfechos primários foram a satisfação do paciente, avaliada pelo escore ISAS-Br, e a adequação da sedação, avaliada pelo cirurgião e medida por uma Escala Numérica de Classificação (NRS) para movimentos. Foram comparadas alterações respiratórias e hemodinâmicas, além do despertar da anestesia, eventos adversos durante a recuperação e tempo para alta hospitalar.
Resultados
Não houve diferença nos escores de satisfação do paciente (mediana ISAS-Br [IQR]: PF 2,64 [2,45–3,00] vs. PDex 3,00 [2,45–3,00], p = 0,252). O grupo PF apresentou escore significativamente menor para movimentos (mediana NRS [IQR]: 0,5 [0,00–2,25] vs. 2,0 [0,00–5,00], p = 0,006). A incidência de eventos intraoperatórios relacionados à respiração e hemodinâmica, assim como dor pós-operatória e náuseas/vômitos pós-operatórios, foi similar entre os grupos. Uma maior proporção de pacientes sedados com PF despertou na sala de cirurgia (75% vs. 35,9%, p < 0,001), e 98,4% do grupo PF contra 92,2% do grupo PDex estavam prontos para alta hospitalar em menos de trinta minutos, p = 0,208.
Conclusão
Doses únicas de fentanil ou dexmedetomidina combinadas com propofol resultaram em satisfação do paciente, segurança e tempos de alta equivalentes. A combinação propofol-fentanil demonstrou superioridade na adequação da sedação sob a perspectiva do cirurgião e facilitou um despertar mais rápido da anestesia.
Palavras-chave
References
1. Rajan N. The emerging landscape of ambulatory surgery and anesthesia. Curr Opin Anaesthesiol. 2023;36:609−10.
2. Warnakulasuriya SR, Patel RC, Singleton GF, Moonesinghe SR. Patient-reported outcomes for ambulatory surgery. Curr Opin Anaesthesiol. 2020;33:768−73.
3. American Society of Anesthesiologists. Distinguishing monitored anesthesia care (“MAC”) from moderate sedation/analgesia (conscious sedation) [Internet]. www.asahq.org [last update 2023 Oct 19; cited 2024 Feb 2]. Available from: https://www. asahq.org/standards-and-practice-parameters/statement-ondistinguishing-monitored-anesthesia-care-from-moderatesedation-analgesia.
4. Williams MR, Ward DS, Carlson D, et al. Evaluating patient-centered outcomes in clinical trials of procedural sedation, part 1 efficacy: sedation consortium on endpoints and procedures for treatment, education, and research recommendations. Anesth Analg. 2017;124:821−30.
5. Das S, Ghosh S. Monitored anesthesia care: an overview. J Anaesthesiol Clin Pharmacol. 2015;31:27−9.
6. Seyam SH, Aboelsuod MAA, Ahmed IMA, Hassan AE. Sedation for colonoscopy procedures using dexmedetomidine versus propofol-fentanyl infusions: a prospective randomized controlled trial. Turk J Anaesthesiol Reanim. 2024;52:60−7.
7. Sahinovic MM, Struys MMRF, Absalom AR. Clinical pharmacokinetics and pharmacodynamics of propofol. Clin Pharmacokinet. 2018;57:1539−58.
8. Peng K, Liu HY, Wu SR, Liu H, Zhang ZC, Ji FH. Does propofol anesthesia lead to less postoperative pain compared with inhalational anesthesia?: a systematic review and meta-analysis. Anesth Analg. 2016;123:846−58.
9. Miller KA, Andolfatto G, Miner JR, Burton JH, Krauss BS. Clinical practice guideline for emergency department procedural sedation with propofol: 2018 update. Ann Emerg Med. 2019;73:470−80.
10. Comer SD, Cahill CM. Fentanyl: receptor pharmacology, abuse potential, and implications for treatment. Neurosci Biobehav Rev. 2019;106:49−57.
11. Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019;38:169−72.
12. Lee S. Dexmedetomidine: present and future directions. Korean J Anesthesiol. 2019;72:323−30.
13. Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010;110:47−56.
14. Na HS, Song IA, Park HS, Hwang JW, Do SH, Kim CS. Dexmedetomidine is effective for monitored anesthesia care in outpatients undergoing cataract surgery. Korean J Anesthesiol. 2011;61:453−9.
15. Babu TR, Kumar MRA, Anup NR, Shetty SM. Dexmedetomidine as an adjunct to propofol in patients undergoing elective endoscopic retrograde cholangio-pancreaticography − a doubleblind randomized controlled study. J Pharm Bioallied Sci. 2024;16:S399−402.
16. Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017;83:1248−54.
17. Goettel N, Bharadwaj S, Venkatraghavan L, Mehta J, Bernstein M, Manninen PH. Dexmedetomidine vs propofol-remifentanil conscious sedation for awake craniotomy: a prospective randomized controlled trial. Br J Anaesth. 2016;116:811−21.
18. Chernik D, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, et al. Validity and reliability of the Observer’s Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990;10:244−51.
19. Dexter F, Aker J, Wright W. Development of a measure of patient satisfaction with monitored anesthesia care. Anesthesiology. 1997;87:865−73.
20. Moritz NMP, Moritz JE, Parma GOC, Dexter F, Traebert J. Crosscultural adaptation and validation of the Iowa satisfaction with anesthesia scale for use in Brazil: a cross-sectional study. Braz J Anesthesiol. 2024;74:744471.
21. Dexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995;82:896−902.
22. Dean AG, Sullivan KM, Soe MM. OpenEpi. OpenEpi: Open-Source Epidemiologic Statistics for Public Health. Versao 3.01 [Inter- ~ net]. [cited 2022 Jul 10]. Available from: https://www.openepi.com/SampleSize/SSMean.htm.
23. Love J, Dropmann D, Selker R, et al. The Jamovi project. Jamovi versao 2.3.9 [software]. 2013. Available from ~ https:// www.jamovi.org.
24. Tekeli AE, Oguz AK, Tuncdemir YE, Almali N. Comparison of dex- ¸ medetomidine-propofol and ketamine-propofol administration during sedation-guided upper gastrointestinal system endoscopy. Medicine. 2020;99:e23317.
25. Singh A, Iyer K V, Maitra S, et al. Ketamine and dexmedetomidine (keto-dex) or ketamine and propofol (keto-fol) for procedural sedation during endoscopic retrograde cholangiopancreatography: which is safer? A randomized clinical trial. Indian J Gastroenterol. 2022;41:583−90.
26. Muller S, Borowics SM, Fortis EAF, et al. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc. 2008;67:651−9.
27. Oh C, Lee J, Lee J, et al. Apnea during moderate to deep sedation using continuous infusion of remimazolam compared to propofol and dexmedetomidine: a retrospective observational study. PLoS One. 2024;19:e0301635.
28. Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011;113:364−8.
29. Batbaatar E, Dorjdagva J, Luvsannyam A, Savino MM, Amenta P. Determinants of patient satisfaction: a systematic review. Perspect Public Health. 2017;137:89−101.
30. Wan Hassan WMN, Tan HS, Mohamed Zaini RH. Comparison of the effects of dexmedetomidine on the induction of anaesthesia using Marsh and Schnider pharmacokinetic models of propofol target-controlled infusion. Malays J Med Sci. 2018;25:24−31.
Submitted date:
10/16/2024
Accepted date:
04/22/2025
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