Protocolized Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Adults Undergoing Emergency Surgery for Secondary Peritonitis: A Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cumulative duration of MAP below 65 mmHg during induction
研究概览
简要总结
This study tests whether giving a low-dose norepinephrine infusion just before induction of anesthesia can reduce low blood pressure during emergency surgery for peritonitis. Adults with secondary peritonitis who are scheduled for emergency surgery and have stable blood pressure after initial resuscitation will be randomly assigned to receive either norepinephrine or placebo (normal saline) during induction of anesthesia. The main outcome is the cumulative time spent with mean arterial pressure (MAP) below 65 mmHg from the start of propofol administration to 10 minutes after endotracheal intubation. The study will also evaluate rescue vasopressor use, heart rate changes, drug-related adverse events, and selected early postoperative outcomes.
详细描述
The study is a single-center, randomized, double-blind, placebo-controlled interventional trial conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam.
Adults undergoing emergency surgery for secondary peritonitis often have marked hemodynamic vulnerability during induction of general anesthesia because of systemic inflammation, vasodilation, capillary leak, and relative hypovolemia. Propofol-based induction may further reduce arterial pressure and organ perfusion in this setting.
Participants who meet eligibility criteria and have a mean arterial pressure (MAP) of at least 65 mmHg after initial resuscitation, without ongoing vasopressor support, will be enrolled and randomized 1:1 to a norepinephrine infusion group or a placebo group.
In the intervention group, norepinephrine will be infused at 0.05 micrograms/kg/min starting 3 minutes before fentanyl. In the placebo group, 0.9% sodium chloride will be infused with the same presentation, timing, and pump settings.
All participants will undergo a standardized induction protocol with fentanyl, titrated propofol, rocuronium, arterial line monitoring before induction, and protocolized hemodynamic rescue treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study drug syringes will be prepared by personnel not involved in anesthesia management, postoperative assessment, or statistical analysis. Participants, anesthesia care providers, investigators, outcome assessors, and statisticians will remain blinded to treatment allocation until database lock unless unblinding is required for participant safety.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Secondary peritonitis requiring emergency surgery under general anesthesia with endotracheal intubation.
- •Planned induction with fentanyl, propofol, and rocuronium according to the study protocol.
- •Hemodynamically stabilized after initial resuscitation, with MAP at least 65 mmHg and no ongoing vasopressor infusion before induction.
- •ASA physical status I to III.
- •Written informed consent from the participant or a legally authorized representative.
排除标准
- •Allergy or contraindication to norepinephrine, propofol, fentanyl, or rocuronium.
- •Severe cardiovascular disease likely to confound hemodynamic assessment, including decompensated heart failure, acute coronary syndrome, severe arrhythmia, severe valvular disease, or major cardiomyopathy.
- •Ongoing vasopressor therapy before induction.
- •Shock before surgery, including hypovolemic, septic, or cardiogenic shock.
- •Severe hypertension before induction (systolic blood pressure >180 mmHg or mean arterial pressure >110 mmHg).
- •Severe peripheral vascular disease or clinically significant limb ischemia.
- •Current monoamine oxidase inhibitor use.
- •Pregnancy or breastfeeding.
- •Contraindication to arterial catheter placement.
- •Refusal of consent.
研究组 & 干预措施
0.9% sodium chloride infusion
Participants receive 0.9% sodium chloride with the same presentation, timing, and infusion settings as the intervention arm during standardized induction of general anesthesia.
干预措施: Placebo (Other)
Low-dose norepinephrine infusion
Participants receive a norepinephrine infusion at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during standardized induction of general anesthesia.
干预措施: Norepinephrine (0.05 μg/kg/min) (Drug)
结局指标
主要结局
Cumulative duration of MAP below 65 mmHg during induction
时间窗: From start of propofol administration to 10 minutes after endotracheal intubation
Total time with mean arterial pressure below 65 mmHg, derived from time-stamped arterial line data after removal of artifacts.
次要结局
- Incidence of severe hypotension (MAP below 55 mmHg)(From start of propofol administration to 10 minutes after endotracheal intubation)
- Largest decrease in MAP from baseline(From baseline before study-drug infusion to 10 minutes after endotracheal intubation)
- Number of Participants Requiring Rescue Vasopressor(From baseline before study-drug infusion to 10 minutes after endotracheal intubation)
- Number of Participants With Bradycardia(From start of propofol administration to 10 minutes after endotracheal intubation)
- Postoperative lactate concentration(Preoperative baseline and within 24 hours after surgery)
- Total Rescue Vasopressor Dose(From baseline before study-drug infusion to 10 minutes after endotracheal intubation)
- Number of Participants With Tachycardia(From start of propofol administration to 10 minutes after endotracheal intubation)
- Number of Participants Requiring Atropine(From start of propofol administration to 10 minutes after endotracheal intubation)
- Number of Participants With Clinically Significant Arrhythmias(From start of propofol administration to 10 minutes after endotracheal intubation)
- Number of Participants Admitted to the Intensive Care Unit After Surgery(From end of surgery to hospital discharge)
- Number of Participants With Early Postoperative Complications(From end of surgery to hospital discharge)
- Postoperative Length of Stay(From end of surgery to hospital discharge)
- Incidence of MAP below 65 mmHg(From start of propofol administration to 10 minutes after endotracheal intubation)
研究者
Nguyen Toan Thang
Consultant Anesthesiologist, Director of Center for Anesthesia and Surgical ICU
Bach Mai Hospital