跳至主要内容
临床试验/NCT07363941
NCT07363941招募中不适用

COMPARISON OF HEMODYNAMIC AND ANAESTHETIC OUTCOMES BETWEEN HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES

Shaheed Mohtarma Benazir Bhutto Institue of Trauma1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2026年1月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
104
试验地点
1
主要终点
HYPOTENSION

研究概览

简要总结

The goal of this clinical trial is to find out whether height-based dosing of spinal anaesthesia provides better hemodynamic stability and anesthetic outcome than conventional fixed dosing in elderly patients undergoing lower limb orthopaedic surgery.The main questions this study aims to answer are:

  1. Does height-based spinal anaesthetic dosing reduce the risk of hypotension and bradycardia during surgery as compared to conventional fixed dosing?
  2. Does it improve anaesthetic outcomes, such as the onset and duration of sensory and motor block?

详细描述

Data collection would begin after the approval of ethical review committee of the institution. This investigation will encompass patients who are scheduled to undergo lower limb orthopaedic surgical procedures within the Department of Anaesthesia, SMBBIT, Karachi. Following a comprehensive description of the study and their acceptance to participate (written consent), the subject will be recruited as detailed in the inclusion criteria.

Data will be collected using a defined data collection proforma to record baseline demographics and clinical characteristics including age, height, gender, and residential status. Height will be measured in the supine position as the patients will be undergoing lower limb surgeries. The patient will be placed flat on a firm examination table or operating-room bed without a pillow, with legs extended and neutral. To accurately measure height in centimetres, a measuring tape or stadiometer will be placed along the length of the patient's body from the heel to the vertex of the head, using trained staff to ensure precise placement, and the reading will be recorded to the nearest decimal point.

The subjects will be allocated to one of two groups through a computer-generated random number sequence with concealed allocation to mitigate selection bias and safeguard the integrity of the randomization process. Allocation concealment will be accomplished by the Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) method, conducted by a blinded independent researcher not involved in subject recruitment, surgical procedure, or clinical assessment. In the operating room, baseline pulse rate and mean arterial pressure will be measured before spinal anaesthesia is induced. Intravenous access will be established, and patients will be preloaded with Ringer Lactate (10 ml/kg) prior to induction of spinal anaesthesia.

Spinal anaesthesia will be provided in the sitting position, aseptically at the level of L3-4 vertebra. Group A will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally, whereas patients in Group B will be administered 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone. Subsequent to the administration of spinal anaesthesia, patients will be positioned in the supine orientation; sensory blockade will be evaluated utilizing the pinprick method with a blunt-tipped 23-gauge needle at the T10 dermatome level, while motor blockade will be assessed employing the Bromage scale. The specific time at which the most effective sensory and motor blockade is achieved will be documented in accordance with the established operational definition.

The hemodynamic (heart rate and mean arterial pressure) will be continuously monitored. The procedure and the principal investigator (in consultation with a faculty consultant with >5 years' experience) will mark the findings of "bradycardia" and "hypotension" based on the operational definition on the proforma. The early postoperative period will be followed in all patients in order to know sensory and motor blockade duration by operational definition, and each result will be written. The principal investigator will record collected data on a predesigned proforma. Confidentiality will be ensured along with data security measures allowing only authorized personnel access to all information. The study is produced to be directly relevant with its aims, and rigorous exclusion criteria will be used in minimizing potential biases or confounders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This study is single blind, assessor is kept blind because participants are difficult to mask due to well distinguished treatment plan.

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals aged 60 to 80 years. Either gender (male or female). Patients who are ASA physical status I-III. Individuals scheduled to undergo elective lower limb orthopaedic surgeries (e.g., fracture fixation, total knee replacement, open reduction and internal fixation).
  • Patients planned to receive spinal anaesthesia as the primary anaesthetic technique.
  • Those who provide informed written consent for participation in the study.

排除标准

  • Individuals exhibiting a stature inferior to 150 cm. Patients receiving anti-hypertensive drugs or those on beta blockers or beta-agonists.
  • Patients with a history of neurological disease like CVA or Parkinsonism. Patients presenting with sepsis (≥ 2 positive SIRS criteria with positive aseptically obtained blood or wound culture).
  • Patients with a history of coagulation disorders like haemophilia or vWD or those with a history of anti-platelet drug intake in the last 2 weeks.
  • Individuals possessing a documented history of hypersensitivity reactions to pharmacological agents utilized in the research.
  • Patients who will be diagnosed with a skin infection at the spinal needle puncture site.
  • Patients undergoing emergency orthopaedic procedures requiring immediate intervention

研究组 & 干预措施

Group A

Experimental

Participants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally

干预措施: Group A : Spinal Anaesthetic Dose (Drug)

Group B

Active Comparator

Participants will recieve 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally

干预措施: Group B : Conventional Dose (Drug)

结局指标

主要结局

HYPOTENSION

时间窗: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade

Defined as a decrease of ≥20% in mean arterial pressure (MAP) from baseline or an absolute MAP \<65 mmHg at any point during surgery, recorded using non-invasive blood pressure monitoring at five-minute intervals

BRADYCARDIA

时间窗: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade

It will be defined in terms of a heart rate of ≤ 60 beats/minute during surgery

ONSET OF SENSORY BLOCK

时间窗: Subsequent to the administration of spinal anaesthesia till the attainment of sensory blockade

It will be defined as the time interval (in minutes) from the completion of intrathecal injection of bupivacaine to the loss of pinprick sensation at the T10 dermatome. The assessment will be carried out using a sterile blunt 23-gauge needle at one-minute intervals until loss of sensation is confirmed.

DURATION OF SENSORY BLOCK

时间窗: Subsequent to the administration of spinal anaesthesia till the end of sensory blockade

It will be defined as the time interval (in minutes) from the onset of sensory block at the T10 dermatome (confirmed by loss of pinprick sensation) to the reappearance of sensation at the same dermatome level. The response will be assessed every 5 minutes using a sterile blunt 23-gauge needle.

ONSET OF MOTOR BLOCK

时间窗: Subsequent to the administration of spinal anaesthesia till the attainment of motor blockade

It will be defined as the time duration (in minutes) between the completion of intrathecal administration of bupivacaine until the patient develops Bromage III

DURATION OF MOTOR BLOCK

时间窗: Subsequent to the administration of spinal anaesthesia till the end of motor blockade

The duration of motor block is defined as the time duration (in minutes) from the onset of motor block (inability to move feet) until the patient regains the ability to voluntarily move both feet.

次要结局

未报告次要终点

研究者

发起方
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jehanzaib Muhammad Azam

Jehanzaib Muhammad Azam

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

研究点 (1)

Loading locations...

相似试验

HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC... | 临床试验