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.

Prevention of post spinal Shivering: using combination of Ketamine plus midzolam Vs Tramadol and placebo.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011995

Enrollment

Registered

2018-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients posted for surgery under spinal analgesia PAC fit

Interventions

Intervention1: The effect of Inj Ketamine plus Midazolam versus Tramadol and Placebo was compared.: Not applicable Intervention2: SINGLE ARM INJECTION: Not applicable Intervention3: The drug combinat

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactKanhaiya Lal Kishnani

Department of Anesthesia Peoples College of Medical Sciences & Research Centre

drkishnani@gmail.com07554004010

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026