A comparative study determining the effect of pre-emptive intravenous Glycopyrrolate versus Ondansetron in preventing spinal hypotension in patients undergoing elective inguinal hernioplasty at a tertiary care hospital
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To measure the effectiveness of pre emptive
研究概览
简要总结
Spinal anaesthesia is an extensively used anaesthetic procedure owing to its technical simplicity,
faster onset, and effective motor and sensory blockade.
Hypotension is one of the most frequent complications during subarachnoid block due to the
sympathetic blockade which sequentially decreases the systemic vascular resistance and cardiac
output leading to hypotension.
Prevention and prompt management of hypotension is of utmost importance to prevent organ
ischemia. Sympathomimetics are usually administered reactively which is the administration of
drugs after the appearance of spinal hypotension. A more logical approach is proactively which is
giving the drugs preemptively to prevent the occurrence of hypotension following subarachnoid
block.
This pre-emptive or proactive approach has reduced the incidence and severity of spinal
anaesthesia induced hypotension in many studies conducted worldwide.
Glycopyrrolate is a quaternary amine with anti-muscarinic effects and has been successfully used in
preventing spinal anaesthesia induced hypotension in the elderly population, undergoing abdominal
and lower limb surgeries.
Bezold Jarisch reflex (BJR) is mediated by stimulation of intracardiac mechanoreceptors and
chemoreceptors.
Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are also required for the activation of
the Bezold Jarisch reflex. Ondansetron, a 5-Hydroxytryptamine3 (5HT3) receptor antagonist is
reported to suppress bradycardia and hypotension by preventing this Bezold Jarisch reflex.
In this study, we aim to determine the effect of pre-emptive intravenous Glycopyrrolate versus
Ondansetron in preventing spinal hypotension in patients undergoing elective unilateral inguinal
hernioplasty under subarachnoid block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Elective unilateral inguinal hernioplasty surgeries under spinal anaesthesia 2.American Society of Anaesthesiologists Grade I and Grade II of male/female gender.
- •3.Patients aged between 18 to 60 years.
- •4.Patients with BMI less than 30 kg/m
- •5.Patients with height between 155 -170 centimeters.
排除标准
- •Patients on Beta blockers, Calcium channel blockers, and alpha 2 agonists
- •Gross spinal abnormality.
- •Infection at the site of lumbar puncture.
- •Pre-existing Hemorrhagic diathesis.
- •Pre-existing Neurological disorders.
- •History of allergy to the study drugs.
结局指标
主要结局
To measure the effectiveness of pre emptive
时间窗: Every 2 min for first 20 min | Every 5 min thereafter till end of surgery
intravenous ondansetron and glycopyrrolate in
时间窗: Every 2 min for first 20 min | Every 5 min thereafter till end of surgery
prevention of spinal hypotension by measuring
时间窗: Every 2 min for first 20 min | Every 5 min thereafter till end of surgery
the Mean Arterial Pressure(MAP) to assess the
时间窗: Every 2 min for first 20 min | Every 5 min thereafter till end of surgery
incidence and severity of hypotension after
时间窗: Every 2 min for first 20 min | Every 5 min thereafter till end of surgery
administration of spinal anesthesia
时间窗: Every 2 min for first 20 min | Every 5 min thereafter till end of surgery
次要结局
- To determine the total vasopressor requirement(after administration of spinal anaesthesia)
研究者
Dr Krishna Susrutha Kocherlakota
Kodagu institute of medical sciences