Efficacy of Nalbuphine in Attenuation of Hemodynamic Response to Laryngoscopy and Orotracheal Intubation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Mean Arterial Pressure (MAP) change following laryngoscopy and orotracheal intubation
研究概览
简要总结
Laryngoscopy and placement of a breathing tube during general anesthesia can cause temporary increases in blood pressure and heart rate. These changes may be harmful in some patients. Nalbuphine is an opioid pain medicine that may reduce these cardiovascular responses.
This study evaluated whether intravenous nalbuphine, given before anesthesia induction, reduces changes in mean arterial blood pressure during laryngoscopy and orotracheal intubation compared with placebo (normal saline).
Adult patients undergoing elective surgery under general anesthesia were randomly assigned to receive either nalbuphine or placebo before anesthesia. Blood pressure was measured before drug administration, during intubation, and for several minutes afterward. The results of this study may help guide safe medication use to maintain blood pressure stability during airway management.
详细描述
Laryngoscopy and orotracheal intubation are essential components of general anesthesia but are associated with a sympathoadrenal stress response caused by stimulation of the laryngeal and pharyngeal structures. This response may result in transient hypertension and tachycardia due to catecholamine release. Although often well tolerated in healthy individuals, these hemodynamic changes can be undesirable and potentially harmful, particularly in patients with limited cardiovascular reserve.
Opioids have been widely used to attenuate the hemodynamic response to airway manipulation. Nalbuphine is a synthetic opioid with kappa receptor agonist and mu receptor antagonist properties. It provides analgesia with a ceiling effect on respiratory depression and has a lower risk of certain opioid-related adverse effects compared with pure mu agonists. Despite these potential advantages, data regarding the effectiveness of nalbuphine in attenuating intubation-related hemodynamic responses remain limited.
This prospective, randomized, controlled trial was conducted at Hayatabad Medical Complex, Peshawar, Pakistan, between March 2024 and December 2024. Adult patients aged 18 to 60 years with American Society of Anesthesiologists (ASA) physical status I, scheduled for elective surgery under general anesthesia requiring orotracheal intubation, were enrolled. Patients with anticipated difficult airways, cardiovascular disease, hypertension, hepatic or renal disease, pregnancy, opioid allergy, or use of interacting medications were excluded.
Eligible participants were randomly allocated into two groups. The intervention group received intravenous nalbuphine at a dose of 0.2 mg/kg, while the control group received an equivalent volume of normal saline. The study drug was administered five minutes before induction of anesthesia. Anesthesia induction was standardized using propofol and atracurium, followed by Macintosh laryngoscopy and orotracheal intubation performed by experienced anesthetists.
Hemodynamic parameters were recorded at baseline, three minutes after administration of the study drug, immediately after intubation, and at one-minute intervals for five minutes following intubation. The primary outcome measure was mean arterial pressure after laryngoscopy and intubation. Adverse events, including bradycardia, hypotension, nausea, respiratory depression, and other complications, were monitored intraoperatively.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group allocation. Study drugs were prepared by personnel not involved in data collection.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective surgery under general anesthesia requiring laryngoscopy and orotracheal intubation.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Age between 18 and 60 years.
- •Male and female patients.
- •Patients who provide written informed consent.
排除标准
- •Known hypersensitivity to nalbuphine or any opioids.
- •History of cardiovascular disease, including uncontrolled hypertension, arrhythmias, or ischemic heart disease.
- •Respiratory disorders such as asthma, chronic obstructive pulmonary disease, or significant respiratory compromise.
- •Renal or hepatic impairment.
- •Pregnancy or lactation.
- •Use of medications affecting hemodynamic response (e.g., beta-blockers or calcium channel blockers).
- •Emergency surgery.
- •Anticipated difficult airway (Mallampati class III or IV).
研究组 & 干预措施
Placebo (Normal Saline)
Participants in this arm received intravenous normal saline in a volume equivalent to the intervention drug. The placebo was administered five minutes before induction of general anesthesia, followed by standardized induction with propofol and atracurium, laryngoscopy, and orotracheal intubation.
干预措施: Normal saline IV (Drug)
Nalbuphine 0.2 mg/kg
Participants in this arm received intravenous nalbuphine at a dose of 0.2 mg/kg administered five minutes before induction of general anesthesia. Induction was standardized using propofol and atracurium, followed by laryngoscopy and orotracheal intubation.
干预措施: Nalbuphine 0.2 mg/kg (Drug)
结局指标
主要结局
Mean Arterial Pressure (MAP) change following laryngoscopy and orotracheal intubation
时间窗: Immediately after intubation and at 1-minute intervals for 5 minutes post-intubation
MAP will be measured at baseline (before drug administration), 3 minutes after administration of nalbuphine or placebo, immediately after intubation, and at 1-minute intervals for the subsequent 5 minutes. The primary outcome is the difference in MAP between the nalbuphine group and the saline control group, reflecting the efficacy of nalbuphine in attenuating the hemodynamic response to laryngoscopy and intubation.
次要结局
- Heart Rate (HR) change(Immediately after intubation and at 1-minute intervals for 5 minutes post-intubation)
- Incidence of adverse events(Intraoperative and immediate postoperative period)
研究者
Dr. Waseem Ullah
Assistant Professor
Lady Reading Hospital, Pakistan