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The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial.

ABSTRACT: BACKGROUND:The ?2-adrenergic agonist dexmedetomidine (DEX) is a sedative and can be used as an adjunct to hypnotics. The study sought to evaluate the effects of different doses of DEX on the requirements for propofol for loss of consciousness (LOC) in patients monitored via the bispectral index (BIS). METHODS:In this randomized, double-blind, three arm parallel group design and placebo-controlled trial, 73 patients aged between 18 and?~?65?years with a BMI range of 18.0-24.5?kg·m-?2 and an American Society of Anesthesiologists (ASA) grade I or II who were scheduled for general anesthesia at the General Hospital of Ningxia Medical University were included in this study. Anesthesiologists and patients were blinded to the syringe contents. All patients were randomly assigned in a 1:1:1 ratio to receive a 0.5??g·kg-?1 DEX infusion (0.5??g·kg-?1 DEX group; n?=?24), a 1.0??g·kg-?1 DEX infusion (1.0??g·kg-?1 DEX group; n?=?25) or a saline infusion (control group; n?=?24) for 10?min. Propofol at a concentration of 20?mg·kg-?1·h-?1 was then infused at the end of the DEX or saline infusion. The propofol infusion was stopped when the patient being infused lost consciousness. The primary endpoint were propofol requirements for LOC and BIS value at LOC. RESULTS:The data from 73 patients were analyzed. The propofol requirements for LOC was reduced in the DEX groups compared with the control group (1.12?±?0.33?mg·kg-?1 for the 0.5??g·kg-?1 DEX group vs. 1.79?±?0.39?mg·kg-?1 for the control group; difference, 0.68?mg·kg-?1 [95% CI, 0.49 to 0.87]; P?=?0.0001) (0.77?±?0.27?mg·kg-?1 for the 1.0??g·kg-?1 DEX group vs. 1.79?±?0.39?mg·kg-?1 for the control group; difference, 1.02?mg·kg-?1 [95% CI, 0.84 to 1.21]; P?=?0.0001). The propofol requirements for LOC was lower in the 1.0??g·kg-?1 DEX group than the 0.5??g·kg-?1 DEX group (0.77?±?0.27?mg·kg-?1 vs. 1.12?±?0.33?mg·kg-?1, respectively; difference, 0.34?mg·kg-?1 [95% CI, 0.16 to 0.54]; P?=?0.003). At the time of LOC, the BIS value was higher in the DEX groups than in the control group (67.5?±?3.5 for group 0.5??g·kg-?1 DEX vs. 60.5?±?3.8 for the control group; difference, 7.04 [95% CI, 4.85 to 9.23]; P?=?0.0001) (68.4?±?4.1 for group 1.0??g·kg-?1 DEX vs. 60.5?±?3.8 for the control group; difference, 7.58 [95% CI, 5.41 to 9.75]; P?=?0.0001). CONCLUSION:The study showed that DEX (both 0.5 and 1.0??g·kg-?1 DEX) reduced the propofol requirements for LOC. DEX pre-administration increased the BIS value for LOC induced by propofol. CLINICAL TRIAL REGISTRATION:The study was registered at ClinicalTrials.gov (trial ID: NCT02783846 on May 26, 2016).

SUBMITTER: Gu Y

PROVIDER: S-EPMC7183661 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial.

Gu Yang Y Yang Fan F Zhang Yonghai Y Zheng Junwei J Wang Jie J Li Bin B Ma Tao T Cui Xiang X Lu Kaimei K Ma Hanxiang H

BMC anesthesiology 20200425 1

<h4>Background</h4>The α<sub>2</sub>-adrenergic agonist dexmedetomidine (DEX) is a sedative and can be used as an adjunct to hypnotics. The study sought to evaluate the effects of different doses of DEX on the requirements for propofol for loss of consciousness (LOC) in patients monitored via the bispectral index (BIS).<h4>Methods</h4>In this randomized, double-blind, three arm parallel group design and placebo-controlled trial, 73 patients aged between 18 and ~ 65 years with a BMI range of 18.0 ...[more]

PMID: 32334510

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Project description:Background: Propofol injection pain, despite various interventions, still occurs during the anesthesia induction and causes intense discomfort and anxiety in patients. This study aimed to explore the effect of intravenous dexmedetomidine on propofol injection pain prior to anesthesia induction with propofol at 4°C. Methods: A total of 251 patients (American Society of Anesthesiologists I-II) who underwent oral and maxillofacial surgery were randomly assigned to a combination group (n = 63), lidocaine group (n = 62), dexmedetomidine group (n = 63), and placebo-control group (n = 63); they received 0.5 ug/kg dexmedetomidine prior to anesthesia induction with propofol at 4°C, 40 mg lidocaine, 0.5 ug/kg dexmedetomidine prior to anesthesia induction, and normal saline, respectively. Incidence of pain, pain intensity, and reaction to the pain stimulus were evaluated by using verbal categorial scoring (VCS), a numerical rating scale (NRS), and the Surgical Pleth Index (SPI), respectively. In addition, hemodynamic parameters such as heart rate (HR) and mean arterial pressure (MAP) were also measured. The VCS and NRS were evaluated at 5 s after propofol injection. In addition, SPI, HR, and MAP were evaluated at three time points (before anesthesia induction and 5 and 30 s after propofol injection). Results: The incidence of pain in the combination group (51%) was significantly lower than that in the lidocaine group (71%), dexmedetomidine group (67%), or placebo-control group (94%) (p < 0.001). VCS and NRS scores in the combination group were also lower compared with the other three groups (p < 0.001), with no statistically significant differences between the lidocaine group and dexmedetomidine group (p > 0.05). The SPI of the combination group decreased significantly in comparison with the other three groups at 5 s after propofol injection (F = 96.23, p < 0.001) and 30 s after propofol injection (F = 4.46, p = 0.005). Further comparisons between HR and MAP revealed no significant differences across the groups (p > 0.05). Conclusion: Because of the sedative nature of dexmedetomidine and analgesic effect of low temperature, this study showed that intravenous dexmedetomidine prior to anesthesia induction with propofol at 4°C is highly effective in attenuating the incidence and severity of pain during injection compared with lidocaine (40 mg), dexmedetomidine 0.5 ug/kg) and placebo. This approach was not associated with any anesthesia complications. Clinical Trial Registration: ClinicalTrials.gov, identifier: ChiCTR-2000034663.

Project description:IntroductionThe use of Bispectral Index (BIS) monitors for assessing depth of sedation has led to a reduction in both the incidence of awareness and anaesthetic consumption in total intravenous anaesthesia. However, these monitors are vulnerable to artefacts. In addition to the processed number, the raw frontal electroencephalogram (EEG) can be displayed as a curve on the same monitor. Anaesthesia practitioners can learn to interpret the EEG in a short tutorial and may be quicker and more accurate thanBIS in assessing anaesthesia depth by recognising EEG patterns. We hypothesise that quality of recovery (QoR) in patients undergoing laparoscopic surgery is better, if propofol is titrated by anaesthesia practitioners able to interpret the EEG.Methods and analysisThis is a multicentre, double-blind (patients and outcome assessors) randomised controlled trial taking place in four Swiss hospitals. Patients aged 18 years or older undergoing laparoscopic procedures with general anaesthesia using propofol and anaesthesia practitioners with more than 2 years experience will be eligible. The primary study outcome is the difference in QoR 24 hours after surgery. Secondary outcomes are propofol consumption, incidence of postoperative nausea and vomiting (PONV) and postoperative delirium.QoR and propofol consumption are compared between both groups using a two-sample t-test. Fisher's exact test is used to compare the incidences of PONV and delirium. A total of 200 anaesthesia practitioners (and 200 patients) are required to have an 80% chance of detecting the minimum relevant difference for the QoR-15 as significant at the 5% level assuming a SD of 20.Ethics and disseminationEthical approval has been obtained from all responsible ethics committees (lead committee: Ethikkommission Nordwest- und Zentralschweiz, 16 January 2021). The findings of the trial will be published in a peer-reviewed journal, presented at international conferences, and may lead to a change in titrating propofol in clinical practice.Trial registration numberwww.Clinicaltrialsgov:NCT04105660.

Dataset Information

The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial.

Publications

The effects of different doses of dexmedetomidine on the requirements for propofol for loss of consciousness in patients monitored via the bispectral index: a double-blind, placebo-controlled trial.

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