Comparison of propofol and midazolam on patients undergoing spinal surgery with intraoperative wake-up test: randomized clinical trial

Canbay, Özgür; Altıparmak, Başak; Çelebi, Nalan; Karagoz, Heves; Saricaoglu, Fatma

doi:10.1016/j.bjane.2013.10.003

“…A study by the American Society of Anesthesiologists found marked heterogeneity of BIS scores, making it difficult to predict the depth of sedation. Originally developed for propofol, its relation with depth of sedation may not be independent of anesthetic agent [9][10][11][12]. Considering that our study was a single-arm trial of an ultra-shortacting benzodiazepine with rapid onset and short duration of action, we assessed patients' depth of sedation in a more direct fashion rather than using BIS index.…”

Section: Discussionmentioning

confidence: 99%

“…Considering that the Bispectral Index (BIS) was originally developed for propofol, and studies have shown that the correlation between depth of sedation and the BIS index was weaker for the benzodiazepine agonist midazolam [9][10][11][12], we decided to use Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale alone to evaluate the depth of sedation [13].…”

Section: Pretreatment and Techniquementioning

confidence: 99%

Moderate sedation with single-dose remimazolam tosilate in elderly male patients undergoing transurethral resection of the prostate with spinal anesthesia: a prospective, single-arm, single-centre clinical trial

Zhao

¹

,

Chen

²

,

Zhang

³

et al. 2022

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Background Remimazolam tosilate (RT) is a newly listed benzodiazepine for sedation and anesthesia featuring quick onset of effects, short maintenance and recovery times, which is currently under research. This trial was conducted to determine the median effective dose (ED50) and the 95% effective dose (ED95) of single-dose remimazolam for moderate sedation in elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia, and to evaluate its efficacy and safety. Methods Thirty male patients aged 65–80 years old were recruited for selective TURP. Remimazolam was administered intravenously to pain-free patients (VAS score < 1) within 1 min of successful spinal anesthesia by the same anesthesiologist. We used modified Dixon’s up-and-down sequential allocation method to determine the ED50 and ED95 of the agent with an initial dosage of 0.1 mg/kg. Successful sedation was defined as an MOAA/S score ≤ 3 and above 1. A score of > 3 was deemed as failed sedation. Recruitment continued until ten independent pairs (from successful sedation to failed sedation) would give a reliable estimation of the ED50 and ED95 of RT and their 95% confidence intervals. Results The ED50 of remimazolam was 0.063 (95% C.I. 0.045–0.073) mg/kg. Its ED95 was 0.079 (95% C.I. 0.07–0.137) mg/kg. Remimazolam was safe in its application. Conclusions A single-dose of RT proves to be safe for assisted sedation during TURP in elderly male patients under spinal anesthesia with a lower incidence of adverse events. Its ED50 and ED95 were 0.063 mg/kg and 0.079 mg/kg, respectively. Trial registration http://www.chictr.org.cn (ChiCTR2100051912).

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“…A study by the American Society of Anesthesiologists found marked heterogeneity of BIS scores, making it di cult to predict the depth of sedation. Originally developed for propofol, its relation with depth of sedation may not be independent of anesthetic agent [9][10][11][12]. Considering that our study was a single-arm trial of an ultra-short-acting benzodiazepine with rapid onset and short duration of action, we assessed patients' depth of sedation in a more direct fashion rather than using BIS index.…”

Section: Discussionmentioning

confidence: 99%

“…Considering that the Bispectral Index (BIS) was originally developed for propofol, and studies have shown that the correlation between depth of sedation and the BIS index was weaker for the benzodiazepine agonist midazolam [9][10][11][12], we decided to use Modi ed Observer's Assessment of Alertness/Sedation (MOAA/S) scale alone to evaluate the depth of sedation [13].…”

Section: Pretreatment and Techniquementioning

confidence: 99%

Moderate Sedation with Single-Dose Remimazolam Tosilate in Elderly Male Patients Undergoing Transurethral Resection of the Prostate with Spinal Anesthesia: A Prospective, Single-Arm, Aingle-Centre Clinical Trial

Zhao

¹

,

Chen

²

,

Sun

³

et al. 2022

Preprint

0

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Background Remimazolam tosilate (RT) is a newly listed benzodiazepine for sedation and anesthesia featuring quick onset of effects, short maintenance and recovery times, which is currently under research. This trial was conducted to determine the median effective dose (ED50) and the 95% effective dose (ED95) of single-dose remimazolam for moderate sedation in elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia, and to evaluate its efficacy and safety. Methods Thirty male patients aged 65–80 years old were recruited for selective TURP. Remimazolam was administered intravenously to pain-free patients (VAS score < 1) within 1 min of successful spinal anesthesia by the same anesthesiologist. We used modified Dixon’s up-and-down sequential allocation method to determine the ED50 and ED95 of the agent with an initial dosage of 0.1 mg/kg. Successful sedation was defined as an MOAA/S score ≤ 3 and above 1. A score of > 3 was deemed as failed sedation. Recruitment continued until ten independent pairs (from successful sedation to failed sedation) would give a reliable estimation of the ED50 and ED95 of RT and their 95% confidence intervals. Results The ED50 of remimazolam was 0.063 (95% C.I. 0.045–0.073) mg/kg. Its ED95 was 0.079 (95% C.I. 0.07–0.137) mg/kg. Remimazolam was safe in its application. Conclusions A single-dose of RT proves to be safe for assisted sedation during TURP in elderly male patients under spinal anesthesia with a lower incidence of adverse events. Its ED50 and ED95 were 0.063 mg/kg and 0.079 mg/kg, respectively. Trial registration: http://www.chictr.org.cn (ChiCTR2100051912)

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“…In non-intubated brain injured patients, or with the development of PRIS, dexmedetomidine should be the primary sedative. Midazolam use is not recommended for sedation because it precludes the ability to perform reliable, serial NWTs (93); it is associated with greater ICU length of stay, duration of mechanical ventilation, and delirium compared to propofol or dexmedetomidine (109); and is associated with dramatically prolonged time to awakening compared to propofol (110)(111)(112)(113) and dexmedetomidine (114,115). Despite the numerous pitfalls of midazolam use, it remains one of the most common sedatives utilized in ICUs (3).…”

Section: Choice Of Sedativementioning

confidence: 99%

Neurologic Assessment of the Neurocritical Care Patient: The Neurologic Wake-Up Test

Musick¹,

Alberico²

2020

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0

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Sedation is a ubiquitous practice in ICUs and NCCUs. It has the benefit of reducing cerebral energy demands, but also precludes an accurate neurologic assessment. Because of this, sedation is intermittently stopped for the purposes of a neurologic assessment, which is termed a neurologic wake-up test (NWT). NWTs are considered to be the gold-standard in continued assessment of brain-injured patients under sedation. NWTs also produce an acute stress response that is accompanied by elevations in blood pressure, respiratory rate, heart rate, and ICP. Utilization of cerebral microdialysis and brain tissue oxygen monitoring indicates that this is not mirrored by alterations in overall cerebral metabolism, and seldom affects oxygenation. The hard contraindications for the NWT are preexisting intracranial hypertension, barbiturate treatment, status epilepticus, and hyperthermia. However, hemodynamic instability, sedative use for primary ICP control, and sedative use for severe agitation or respiratory distress are considered significant safety concerns. Despite ubiquitous recommendation, it is not clear if additional clinically relevant information is gleaned through its use, especially with the contemporaneous utilization of multimodality monitoring. Various monitoring modalities provide unique and pertinent information about neurologic function, however, their role in improving patient outcomes and guiding treatment plans has not been fully elucidated. There is a paucity of information pertaining to the optimal frequency of NWTs, and if it differs based on type of injury. Only one concrete recommendation was found in the literature, exemplifying the uncertainty surrounding its utility. The most common sedative used and recommended is propofol because of its rapid onset, short duration, and reduction of cerebral energy requirements. Dexmedetomidine may be employed to facilitate serial NWTs, and should always be used in the non-intubated patient or if propofol infusion syndrome (PRIS) develops. Midazolam is not recommended due to tissue accumulation and residual sedation confounding a reliable NWT. Thus, NWTs are well tolerated in most patients and remain recommended as the gold-standard for continued neuromonitoring. Predicated upon one expert panel, they should be performed at least one time per day. Propofol or dexmedetomidine are the main sedative choices, both enabling a rapid awakening and consistent NWT.

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Comparison of propofol and midazolam on patients undergoing spinal surgery with intraoperative wake-up test: randomized clinical trial

Abstract: Propofol provided better wake-up conditions and conducted a better neurologic assessment within the same BIS values than midazolam.

Cited by 5 publications

References 18 publications

Moderate sedation with single-dose remimazolam tosilate in elderly male patients undergoing transurethral resection of the prostate with spinal anesthesia: a prospective, single-arm, single-centre clinical trial

Moderate sedation with single-dose remimazolam tosilate in elderly male patients undergoing transurethral resection of the prostate with spinal anesthesia: a prospective, single-arm, single-centre clinical trial

Moderate Sedation with Single-Dose Remimazolam Tosilate in Elderly Male Patients Undergoing Transurethral Resection of the Prostate with Spinal Anesthesia: A Prospective, Single-Arm, Aingle-Centre Clinical Trial

Neurologic Assessment of the Neurocritical Care Patient: The Neurologic Wake-Up Test

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