Patient‐maintained propofol sedation using reaction time monitoring: a volunteer safety study<i>*</i>

Allam, S.; Anderson, Keith; O’Brien, Conor S; Macpherson, J Avril; Gambhir, S.; Leitch, Jason

doi:10.1111/anae.12036

Cited by 9 publications

(9 citation statements)

References 21 publications

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“…However, oxygen desaturation and cardiac side events can occur with the use of propofol sedation during esophagogastroduodenoscopy (EGD) 1 , 2 . For the sake of safety, a pulse oxygen saturation of 90% or less during gastroscopy is considered to indicate hypoxia and require airway intervention to improve oxygen supply and prevent respiratory depression 13 , 14 . During painless gastroscopy, continuous oxygen supply and pulse oximetry are recommended for reducing the incidence of oxygen desaturation, and for the monitoring and timely detection of hypoxia, respectively 15 .…”

Section: Discussionmentioning

confidence: 99%

Clinical application of a novel endoscopic mask: A randomized controlled trial in aged patients undergoing painless gastroscopy

Cai¹,

Huang²,

Zou³

et al. 2017

Int. J. Med. Sci.

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Background: Desaturation during painless gastroscopy in aged patients leads to discontinuation of the procedure, prolonged manipulation time and increased risk of severe complications. An endoscopic nasal mask was designed to control hypoxia during the above procedures. A randomized trial was performed to test whether the novel endoscopic mask is helpful for hypoxia during painless gastroscopy in aged patients.Methods: In this randomized, controlled trial, 141 aged patients undergoing painless gastroscopy were randomized into nasal catheter group (69 patients) and endoscopic mask group (65 patients). Primary outcomes were minimum pulse oxygen saturation and incidence of pulse oxygen saturation ≤ 90%.Results: Finally, 134 aged patients were analyzed, including 69 patients in nasal catheter group and 65 patients endoscopic mask group. The minimum pulse oxygen saturation (96.4% ± 4.8%) was higher in the aged endoscopic mask group than in the aged nasal catheter group (94.3% ± 5.6%, P = 0.0075). The incidence of pulse oxygen saturation ≤ 90% did not significantly differ between the endoscopic mask group and nasal catheter group (6.2% VS 15.9%, P = 0.07). There were no severe adverse events in either groups.Conclusion: The endoscopic mask was safely used in aged patients during painless gastroscopy under propofol sedation and significantly improved the minimum pulse oxygen saturation without increasing time to examination or recovery time.

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Section: Discussionmentioning

confidence: 99%

Clinical application of a novel endoscopic mask: A randomized controlled trial in aged patients undergoing painless gastroscopy

Cai¹,

Huang²,

Zou³

et al. 2017

Int. J. Med. Sci.

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“…The basic reaction time test provides a simple and easy‐to‐use approach, measuring the cognitive integration of visual input and psychomotor function. Also, the test has previously been applied to assess the sedative effects of benzodiazepines and propofol …”

Section: Discussionmentioning

confidence: 99%

“…Also, the test has previously been applied to assess the sedative effects of benzodiazepines and propofol. 27,28 Limitations First, we included only male volunteers in order to standardize the experimental setup. The external validity in regard to gender may therefore be compromised.…”

Section: Adverse Effects Of Melatoninmentioning

confidence: 99%

Pharmacokinetics of high‐dose intravenous melatonin in humans

Andersen

Werner

Rosenkilde

et al. 2015

The Journal of Clinical Pharma

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This crossover study investigated the pharmacokinetics and adverse effects of high-dose intravenous melatonin. Volunteers participated in 3 identical study sessions, receiving an intravenous bolus of 10 mg melatonin, 100 mg melatonin, and placebo. Blood samples were collected at baseline and 0, 60, 120, 180, 240, 300, 360, and 420 minutes after the bolus. Quantitative determination of plasma melatonin concentrations was performed using a radioimmunoassay technique. Pharmacokinetic parameters were estimated by a compartmental pharmacokinetic analysis. Adverse effects included assessments of sedation and registration of other symptoms. Sedation, evaluated as simple reaction times, was measured at baseline and 120, 180, 300, and 420 minutes after the bolus. Twelve male volunteers completed the study. Median (IQR) Cmax after the bolus injections of 10 mg and 100 mg of melatonin were 221,500.0 (185,637.5-326,175.0) pg/mL and 1,251,500.0 (864,375.0-1,770,500.0) pg/mL, respectively; mean (SD) t1/2 was 42.3 (5.6) minutes and 46.2 (6.2) minutes; mean (SD) Vd was 1.6 (0.9) L/kg and 2.0 (0.8) L/kg; mean (SD) CL was 0.0253 (0.0096) L/min · kg and 0.0300 (0.0120) L/min · kg; and median (IQR) AUC0- ∞ , 8,997,633.0 (6,071,696.2-11,602,811.9) pg · min/mL and 54,685,979.4 (36,028,638.6-105,779,612.0) pg · min/mL. High-dose intravenous melatonin did not induce sedation, evaluated as simple reaction times. No adverse effects were reported in the study.

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“…If both conditions are met to allow a sedation increase, the software uses the Schnider model to calculate the required infusion rate to maintain an increase of 0.2 μg/ml in target Ce level (e.g. 0.5 to 0.7 μg/ml, as extensively studied and deemed appropriate in previous research [ 30 ]). This data is then outputted to the B. Braun Perfusor ® fm infusion pump through the serial port, and the pump responds accordingly.…”

Section: Methodsmentioning

confidence: 99%

A Prototype Patient-Maintained Propofol Sedation System Using Target Controlled Infusion for Primary Lower-Limb Arthroplasty

et al. 2019

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Each year, many operations in the UK are performed with the patient awake, without the use of general anaesthesia. These include joint replacement procedures, and in order to reduce patient anxiety, the supervising anaesthetist delivers the sedative propofol intravenously using a target-controlled infusion (TCI) device. However, it is clinically challenging to judge the required effect-site concentration of sedative for an individual patient, resulting in patient care issues related to over or under-sedation. To improve the process, patient-maintained propofol sedation (PMPS), where the patient can request an increase in concentration through a hand-held button, has been considered as an alternative. However, due to the proprietary nature of modern TCI pumps, the majority of PMPS research has been conducted using prototypes in research studies. In this work, a PMPS system is presented that effectively converts a standard infusion pump into a TCI device using a laptop with TCI software. Functionally, the system delivers sedation analogous to a modern TCI pump, with the differences in propofol consumption and dosage within the tolerance of clinically approved devices. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the system as a safe alternative to anaesthetist-controlled TCI procedures. It represents a step forward in the consideration of PMPS as a sedation method as viable alternative, allowing further assessment in clinical trials.

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Patient‐maintained propofol sedation using reaction time monitoring: a volunteer safety study*

Cited by 9 publications

References 21 publications

Clinical application of a novel endoscopic mask: A randomized controlled trial in aged patients undergoing painless gastroscopy

Clinical application of a novel endoscopic mask: A randomized controlled trial in aged patients undergoing painless gastroscopy

Pharmacokinetics of high‐dose intravenous melatonin in humans

A Prototype Patient-Maintained Propofol Sedation System Using Target Controlled Infusion for Primary Lower-Limb Arthroplasty

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