Dataset Information

Effect of propofol combined with opioids on cough reflex suppression in gastroscopy: study protocol for a double-blind randomized controlled trial.

ABSTRACT:

Introduction

The best methods for inducing analgesia and sedation for gastroscopy are still debated but finding an adequate regimen of sedation/analgesia is important. Stimulation of the larynx under sedation can cause reflex responses. Propofol with opioids has been recommended for gastroscopy sedation but the effects on cough reflex suppression remain unclear. This trial will evaluate the effects of propofol combined with small doses of dezocine, oxycodone, sufentanil or fentanyl for gastroscopy. We hypothesise that better performance may be obtained with a combination of propofol and oxycodone. We will observe the incidence and degree of reflex coughing and gagging under sedation when using propofol combined with one of the above drugs or propofol alone.

Methods and analysis

This will be a prospective, randomised, double-blind, controlled trial. ASA I-II level patients aged 18-65 years and scheduled for gastroscopy will be included. It is planned that 500 subjects will be randomised to intravenously receive 2-2.2?mg/kg propofol plus 0.5-0.8??g/kg fentanyl (fentanyl group), 2-2.2?mg/kg propofol plus 0.05-0.08??g/kg sufentanil (sufentanil group), 2-2.2?mg/kg propofol plus 0.04-0.05?mg/kg dezocine (dezocine group), 2-2.2?mg/kg propofol plus 0.04-0.05?mg/kg oxycodone (oxycodone group), or 2.4-3?mg/kg propofol plus 2-2.5?mL saline (control group) for sedation. The primary endpoint is the incidence and degree of reflex coughing and gagging. The secondary endpoints include the occurrence of discomfort or side effects, the use of jaw thrust, assisted ventilation or additional propofol, recovery time, duration of procedure and Steward score.

Ethics and dissemination

This study has been approved by the Institutional Ethics Committee for Clinical Research of Zhongda Hospital, Affiliated to Southeast University (No. 2015ZDSYLL033.0). The results of the trial will be published in an international peer-reviewed journal.

Trial registration

This study has been registered with the Chinese Clinical Trial Register (No. ChiCTR-ICR-15006952).

Trial status

At the time of manuscript submission, the study was in the recruitment phase.

SUBMITTER: Yin N

PROVIDER: S-EPMC5589021 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

Effect of propofol combined with opioids on cough reflex suppression in gastroscopy: study protocol for a double-blind randomized controlled trial.

Yin Ning N Xia Jiangyan J Cao Yi-Zhi YZ Lu Xinjian X Yuan Jing J Xie Jue J

BMJ open 20170901 9

<h4>Introduction</h4>The best methods for inducing analgesia and sedation for gastroscopy are still debated but finding an adequate regimen of sedation/analgesia is important. Stimulation of the larynx under sedation can cause reflex responses. Propofol with opioids has been recommended for gastroscopy sedation but the effects on cough reflex suppression remain unclear. This trial will evaluate the effects of propofol combined with small doses of dezocine, oxycodone, sufentanil or fentanyl for g ...[more]

PMID: 28864688

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Project description:BACKGROUND:Sedation with etomidate or propofol alone during gastroscopy has many side effects. A systematic review and meta-analysis were conducted to evaluate the safety and efficacy of the combined use of propofol and etomidate for sedation during gastroscopy. METHODS:PubMed, Embase, Medline (via Ovid SP), Cochrane library databases, CINAHL (via EBSCO), China Biology Medicine disc (CBMdisc), Wanfang, VIP, and China National Knowledge Infrastructure (CNKI) databases were systematically searched. We included randomized controlled trials (RCTs) comparing the combined use of propofol and etomidate vs etomidate or propofol alone for sedation during gastroscopy. Data were pooled using the random-effects models or fixed-effect model based on heterogeneity. RESULTS:Fifteen studies with 2973 participants were included in the analysis. Compared to propofol alone, the combined use of propofol and etomidate possibly increased recovery time (SMD?=?0.14, 95% CI?=?0.04-0.24; P?=?.005), and the risk for myoclonus (OR?=?3.07, 95% CI?=?1.73-5.44; P?<?.001), injection pain, and nausea and vomiting. Furthermore, compared to propofol alone, the combination of propofol and etomidate produced an apparent beneficial effect for mean arterial pressure (MAP) after anesthesia (SMD?=?1.32, 95% CI?=?0.38-2.26; P?=?.006), SPO2 after anesthesia (SMD?=?0.99, 95% CI?=?0.43-1.55; P?<?.001), apnea or hypoxemia (OR?=?0.16, 95% CI?=?0.08-0.33; P?<?.001), injection pain, and body movement. Further, compared to etomidate alone, the combination of propofol and etomidate reduced the risk for myoclonus (OR?=?0.15, 95% CI?=?0.11-0.22; P?<?.001), body movement, and nausea and vomiting. CONCLUSION:The combination of propofol and etomidate might increase recovery time vs that associated with propofol, but it had fewer side effects on circulation and respiration in patients undergoing gastroscopy. The combined use of propofol and etomidate can improve and produce an apparent beneficial effect on the adverse effects of propofol or etomidate alone, and it was safer and more effective than propofol or etomidate alone.

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Dataset Information

Effect of propofol combined with opioids on cough reflex suppression in gastroscopy: study protocol for a double-blind randomized controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration

Trial status

Publications

Effect of propofol combined with opioids on cough reflex suppression in gastroscopy: study protocol for a double-blind randomized controlled trial.

Similar Datasets

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