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Comparasion of effect of two drug regimes 1) combination of Ketamine plus Midazolam and 2) Tramadol in prevention of shivering in immediate post operative period after surgery under spinal analgesia.

Phase 4
Completed
Conditions
Health Condition 1: null- Patients posted for surgery under spinal analgesia PAC fit
Registration Number
CTRI/2018/02/011995
Lead Sponsor
Peoples College of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
90
Inclusion Criteria

We studied 90 patients between 30 to 65 years undergoing elective surgery under spinal anaesthesia. Divided in three groups of 30 each Group T received 1mg/Kg body wt of Tramadol group group K received Ketamine 0.25 mg/Kg body wt plus Midazolam 40 micro-gm/ kg body wt and group Sreceived saline 0.9% as placebo.

Exclusion Criteria

Patients with a known allergy to any medication under study , with fever (temperature >37.5 C), with known muscle diseases, Parkinsonâ??s disease, impaired hepatic or renal disease, on MAOI or tricyclic antidepressants, alpha 2 agonist or beta receptor blockers as medication treatment were excluded from study. Patients with H/O cardiac arrhythmias or heart failure (NYHA III or IV), those with H/O urinary retention, glaucoma or known alcohol abuse were also excluded. The patients unwilling for regional analgesia were excluded and those patients with failure of effect of spinal analgesia due to patient factors were not included in study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Significant reduction was observed in the incidence of shivering in group T and group K in comparison to group S. There were no significant differences in hypotension and bradycardia in all groups. There was significant sedation in group K in comparison with groups N and S.Timepoint: Significant reduction was observed in the incidence of shivering in group T and group K in comparison to group S. There were no significant differences in hypotension and bradycardia in all groups. There was significant sedation in group K in comparison with groups N and S.
Secondary Outcome Measures
NameTimeMethod
Significant reduction was observed in incidenceof shivering in group T and K.Timepoint: Vitals were recorded at start as base line and at regular time interval of 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 min after spinal anaesthesia.
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