"A COMPARATIVE STUDY OF INTRATHECAL NEOSTIGMINE AND DEXMEDETOMIDINE AS ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN SPINAL ANAESTHESIA FOR ELECTIVE LOWER ABDOMINAL SURGERIES"
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To compare the duration of analgesia in each group.
研究概览
简要总结
Spinal anaesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. However, postoperative pain control is a major problem because spinal anaesthesia using only local anaesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period. A common problem during lower abdominal surgeries under spinal anaesthesia is visceral pain, nausea, and vomiting.[1]
Local anaesthetic lignocaine was used for shorter procedures that can be lasted for 1.5 hours or less. It is associated with shorter duration of action and it was later replaced by Bupivacaine. Bupivacaine is the most commonly employed local anaesthetic for sub arachnoid block. Though bupivacaine is longer acting than lignocaine it has its own demerits like cardio toxicity and its duration of action lasts only for 3 hours, so early need for rescue analgesic in post operative period.[2]
Many adjuvants are commonly used to prolong the duration of analgesia. The addition of opioids to local anaesthetic solution have disadvantages, such as pruritus and respiratory depression. So our concern is to choose an adjuvant with bupivacaine which provides early onset of sensory and motor blockade, stable intra operative condition and prolonging the post operative analgesia with minimal side effects.[3,4]
Neostigmine is an anticholinesterase agent, which inhibits the hydrolysis of acetyl choline. Spinal neostigmine apparently activates descending pain inhibitory systems that rely on a spinal cholinergic interneuron, probably exacerbating a cholinergic tonus that is already activated during the post operative period and seems to be extremely efficient for alleviating somatic pain.[5]
Dexmedetomidine, a new highly selective α2-agonist, acts by binding to presynaptic C fibers and postsynaptic dorsal horn neurons. Their analgesic action is a result of depression of the release of C-fiber transmitters and hyper polarisation of postsynaptic dorsal horn neurons. The prolongation of effect may result from synergism between local anaesthetic and α2 -adrenoceptor agonist, while the prolongation of the motor block of spinal anaesthetics may result from the binding of α2 -adrenoceptor agonists to motor neurons in the dorsal horn.[6]
This prospective, randomized, double-blinded, clinical study aims to determine the effect of intrathecal administration of Neostigmine and Dexmedetomidine as adjuvants on the onset and duration of sensory and motor block and postoperative analgesia produced by spinal Bupivacaine.
This study will be carried out under the Department of Anaesthesiology and Critical Care Medicine, Gauhati Medical College.REFERENCES:
1.Rajni Gupta et al: A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine: Journal of Anaesthesiology Clinical Pharmacology.2011; Volume: 27, Issue: 3, Page: 339-343
2.David L. Brown: spinal,Epidural, and Caudal Anesthesia: Miller’s anesthesia: 7thedition: chapter 51: 1611 -1638
3.Dr.Yoga Narasimha N et al: A clinical study of perioperative effectiveness of adjuvant Neostigmine with intrathecal Bupivacaine for lower abdominal surgeries: IOSR Journal of Dental and Medical Sciences: Volume 2, Issue 3 (Nov- Dec2012), PP 35-39
4.Robert W. Hurley : Acute Postoperative Pain: Miller’s anesthesia : 7th edition : chapter 87 : page : 2757-2780
5.Calvey TN et al : Pharmacokinetics and pharmacological effects of neostigmine in man : Br J Clin Pharmacology : 1979 Feb;7(2):149-55
6.Panzer O et al : Pharmacology of sedative-analgesic agents – Dexmedetomidine, remifentanil, ketamine, volatile anaesthetics and The role of Mu antagonists: Critical Clin : 2009;25:451-69
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 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
- Female
入选标准
- •Age group: 18 to 60 years.
- •ASA physical status 1 and
- •Posted for elective lower abdominal surgeries.
- •Informed and written consent will be taken.
排除标准
- •Allergy to study drugs.
- •Infection at the site of subarachnoid block.
- •Patient with known coagulopathy or patients on anticoagulation therapy.
- •Patient with any mass lesion in abdomen including pregnancy.
- •Patient with history of neurological disorders.
- •Patient with any contraindications to spinal anaesthesia.
- •Patient with morbid obesity.(>-35 kg/m2).
结局指标
主要结局
To compare the duration of analgesia in each group.
时间窗: we record analgesic history intra & post operative within 24 hours. Characteristic of pain monitored with Numerical Rating Scale.
次要结局
- To compare the onset of sensory block in each group.
- To compare the onset of motor block in each group(20 minutes)
- To compare the haemodynamic parameters(24 hours)
- To evaluate untoward side effects.
