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临床试验/CTRI/2017/06/008944
CTRI/2017/06/008944尚未招募不适用

The effect of nebulised magnesium sulphate on the incidence of post operative sore throat

Dr Mallika Balakrishnan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Presence of post operative sore throat at rest

研究概览

简要总结

THE EFFECT OFNEBULISED MAGNESIUM SULPHATE ON THE INCIDENCE OF POST OPERATIVE SORE THROAT

PRINCIPALINVESTIGATOR

Dr.Mallika Balakrishnan , Additional Professor, Department of Anaesthesiology

CO-INVESTIGATORS

 Dr.Bhagyalakshmi Ramesh,Assistant Professor,Department of Anaesthesiology

 Dr.KumarB.G,Junior Resident ,Department of Anaesthesiology

BACKGROUND OF THESTUDY

Intravenous magnesium sulphate is extensively and routinely used inanaesthetic as well as critical care for a wide range of conditions such asTocolysis, Toxemia of pregnancy , Asthma, and Torsades de pointes{1} .Thegeneral incidence of sore throat after tracheal intubation for generalanaesthesia varies from 6.6 to 90%{2}It also increases the duration of hospitalstay{3} . It is known that NMDA (N-Methyl D-Aspartate)receptors play a role innociception and inflammation {4,5}. Magnesium sulphate works as an antagonistof the NMDA receptor.{6}This particular study aims to use magnesium sulphate inthe nebulized format at very low doses from that normally used in otherconditions to study the effect it has in reducing the sensation of postoperative sore throat

 AIM OF THE STUDY

To evaluate the efficacy of pre operative magnesium sulphatenebulization in reducing the incidence of post operative sore throat followinggeneral anaesthesia

DESIGN OF THE STUDY

Routine data based study

 STUDY PERIOD

2017-2018

STUDY POPULATION :

45 patients will be included in the study, and they will be nebulized with 3mlof 225mg isotonic magnesium sulphate for 15 mins pre op,5 minutes prior toinduction.The results will be compared with an equal number of controls who areroutinely nebulized with 3ml  saline for15 mins , 5 mins prior to induction

 SETTING OF THE STUDY

DEPARTMENT OFANAESTHESIOLOGY, REGIONAL CANCER CENTER, TRIVANDRUM

 INCLUSION CRITERIA

Patients of either gender , aged 18-60, belonging to American Societyof Anaesthesiologists (ASA) status 1 or 2 undergoing elective surgery of twohours or more duration requiring endotracheal intubation after acquiringconsent stating the procedure

 EXCLUSION CRITERIA

Patients with neuromuscular disease

Allergy or hypersensitivity to drugs,

Undergoing neck surgeries

Unwilling patients

 METHOD OF STUDY

 The subjects under study will undergo overnight fasting and premedication with oralalprazolam 0.5 mg and pantoprazole 40mg HS and DOS morning.

 The studypopulation will be nebulized with 3ml of 225mg isotonic magnesium sulphate for 15minutes, 5 minutes prior to induction.

 Nebulisation bythe OT staff, briefed by the anaesthesiologists

 Standardmonitoring ,intravenous access will secured.

 Anaesthesia will be induced with fentanyl 2 mcg/kg and propofol 2mg/kg. Tracheal intubation will be facilitated by vecuronium 0.1mg/kg

 7mm ETT tube (PVC)in female patients and 8 mm ETT tube (PVC) in male patients will be the standard sizes chosen

 The ETT cuff will be inflated with air.

 The cuff pressure will be checked just after intubationusing handheld tracheal cuff pressure monitor and then every 30 minutes tillthe end of surgery and will be maintained at 20 cm of H2O.  No nasogastric tube will be inserted. Maintenance of Anesthesia will be with  IPPV withair : oxygen mixture with fio2 of 45% and 1.8% of sevoflurane and intermittent doses of vecuronium as required. Reversal of neuromuscular blockade with neostigmine 0.05 mg/kg andglycopyrrolate 0.01 mg/kg. Extubation will be after the standard extubation criteria were met, and the patientswill be shifted to PACU.

  CONTROL GROUP

The control groupis taken as the group of patients who were nebulized with 3ml of NS for 15 minspre op, 5 minutes prior to induction and data for post operative throat whichwas tabulated for all the patients nebulized with NS in the year 2016 shall beacquired for comparison process

  DATACOLLECTION AND ANALYSIS

 Presence of sorethroat will be noted at rest and on swallowing immediately after extubation, and2 h, 4 h, 10h and 24 h postoperatively

 Drug-related side effects will be noted , if any. Datawill be expressed as mean, and 95% confidence interval of mean.

 For categoricaldata, frequency and percentage of distribution will be calculated and forcomparison between groups,Chi square /fisher’s exact test will be used

Fisher’s exact test; P< 0.05 will  be considered statistically significant.

For quantitative(continuous data) , mean , standard deviation and range  will be calculated .

For comparison of quantitative data betweengroups , students t test  will be used

REFERENCE

PARENT STUDY.YadavM, Chalumuru N, Gopinath R. Effect of magnesium sulfate nebulization on theincidence of postoperative sore throat. J AnaesthesiolClinPharmacol2016;32:168-71

1.http://reference.medscape.com/drug/mgso4-magnesium-sulfate-344444

2.SumathiPA, Shenoy T, Ambareesha M, Krishna HM. Controlled comparison betweenbetamethasone gel and lidocaine jelly applied over tracheal tube to reducepostoperative sore throat, cough, and hoarseness of voice. Br J Anaesth2008;100:215-8.

3..Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery.Br J Anaesth 2002;88:582-4.

4.LinCY, Tsai PS, Hung YC, Huang CJ. L-type calcium channels are involved inmediating the anti-inflammatory effects of magnesium sulphate. Br J Anaesth2010;104:44-51.

5.Zhu MM, Zhou QH, Zhu MH, Rong HB, Xu YM, Qian YN, et al. Effects of nebulizedketamine on allergen-induced airway hyperresponsiveness and inflammation inactively sensitized BrownNorway rats. J Inflamm (Lond) 2007;4:10

6.TurpinF, Dallérac G, Mothet JP. Electrophysiological analysis of the modulation ofNMDAreceptors function by D-serine and glycine in the central nervous system.Methods MolBiol 2012;794:299-312.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender , aged 18-60, belonging to American Society of Anaesthesiologists (ASA) status 1 or 2 undergoing elective surgery of two hours or more duration requiring endotracheal intubation after acquiring consent stating the procedure.

排除标准

  • Patients with neuromuscular disease Allergy or hypersensitivity to drugs, Undergoing neck surgeries Unwilling patients.

结局指标

主要结局

Presence of post operative sore throat at rest

时间窗: immediately after extubation of the endotracheal tube | 2 hours after extubaion of the endotracheal tube | 4 hours after extubaion of the endotracheal tube | 10 hours after extubaion of the endotracheal tube | 24 hours after extubaion of the endotracheal tube

次要结局

  • Presence of sore throat on swallowing(immediately after extubation of the endotracheal tube)

研究者

发起方
Dr Mallika Balakrishnan
申办方类型
Other [self]

研究点 (1)

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