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临床试验/CTRI/2024/07/070922
CTRI/2024/07/070922尚未招募3 期

Effectiveness of superficial cervical plexus block as adjuvant to General anesthesia in reconstructive commando surgery

Mahatma Gandhi Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月27日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
140
试验地点
1
主要终点
To observe attenuation of stress response by assessing hemodynamic variation

研究概览

简要总结

The superficial cervical plexus block (SCPB) is a simple and easy to perform technique which is well elicited for Regional anesthesia of the peri mandibular region It is a potentially valuable anesthetic technique for patient to be operated  with conditions such as ear lobe laceration  submandibular abscesses  injuries to the mandibular region or and neck  thyroid surgeries(superficial neck surgeries),carotid endarterectomy.

Heidenhein launched the lateral approach technique and labat popularized it in the USA.

Regional anesthesia is incomparably the best-established procedure  offering stress free anesthesia  as its simple technique, lower catecholamine release, decreased blood loss due to local vasoconstrictors and sympathetic blockade and negligible morbidity rates with appropriate dosages of the local anesthetic .

Oral surgical and dental procedures are routinely performed in an outpatient setting. Many techniques can be  employed to achieve anesthesia of the dentition and surrounding hard and soft tissues of the maxilla and mandible.  The superficial cervical plexus (CP) has its origins from the ventral rami of the nerve roots C2 to C4.

These  nerve roots provide sensation to the skin and superficial structures of the ear auricle,acromioclavicular joint and anterolateral neck.

These branches exit at a midpoint along the posterior border of the sternocleidomastoid muscle at the same level as the thyroid cartilage notch.

These roots combine to form the four terminal branches  (1)  lesser occipital  (2) greater auricular (3) transverse cervical (4) supraclavicular nerves.

They emerge from behind the posterior border of the SCM.

Anaesthesia will be maintained using 50% o2 with air; and isoflurane (1.2- 1.5 vol %). Duration of surgery will be      defined as the time from surgical incision till closure of the wound. The following variables (SBP, DBP, MAP, HR, SPO2)  would be recorded just before medications (baseline), after SCPB,  after induction,   and 1 min, 5 min, 10min,  15min and 30min 60 min and 90 min  after intubation and than hourly till the completion of surgery in both the groups

Injection Dexmedetomidine 1ug/kg i.v bolus  slowly within 30 minutes followed by intravenous infusion @0.2-0.5ug/kg/hr for maintanace of hemodynamic. Adverse effects such as  bradycardia,  hypotension, respiratory depression, headache, nausea, vomiting or restlessness would  be noted.

Hypertension will be defined as SBP >30% of baseline value or > 140 mmhg and hypotension defined as a decrease in the systolic arterial pressure 30% from baseline values. Similarly tachycardia and bradycardia defined as variations in hr 30% from baseline values. patient shifted to icu, intubated, sedated , paralysed Serum lactate level would be monitoring just pre induction and before extubation.

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Following parameters will be noted capillary refill time, chances of re-expolaration and   hospital stay/icu stay.

A Prospective hospital based  observational study including all cases  in a time period between April 2023 to October 2024.

Data will be collected by using self design questionnaire.

Entire data would be entered into a Microsoft office software and appropriate statistical test will be applied and results will be calculated.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade II III AND IV Patient undergoing head & neck cancer surgery Giving written informed consent for the study.

排除标准

  • Patient with preexisting cardiac disease Uncontrolled Hypertension and Diabetes Asthma Severe renal or hepatic dysfunction.

结局指标

主要结局

To observe attenuation of stress response by assessing hemodynamic variation

时间窗: Days of stay in hospital | Early recovery after Surgery

次要结局

  • Effect on graft viability, re exploration rate ,recovery profile and length of stay in I.C.U and hospital.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR POOJA SHARMA

MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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