Comparison between two doses of pre-emptive I.V. Tramadol in preventing perioperative shivering in Spinal anaesthesia for Urosurgeries.

Comparison of the effects of two different doses of pre-emptive intravenous Tramadol in preventing perioperative shivering in patients undergoing Spinal anaesthesia for urological surgeries – a prospective study in West Bengal. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055269

Enrollment

165

Registered

2023-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: N23- Unspecified renal colic Health Condition 2: N209- Urinary calculus, unspecified

Interventions

Intervention1: Injection Tramadol: No Preemptive dose, only rescue 1mg/kg. The intraoperative period

and then the postoperative period (4 hours). Intervention2: Intravenous Tramadol: Intravenous Tramadol will be administered 5 minutes before the commencement of subarachnoid block (SAB) and thereafte

and then the postoperative period (4 hours) will be observed. Control Intervention1: Group-B: Pre- emptive Tramadol-0.5mg/kg. with rescue Tramadol-1mg/kg.: Group-C: Pre-emptive Tramadol 1mg/kg. with

and then the postoperative period (4 hours). Control Intervention4: Injection Tramadol: Pre-emptive Tramadol-1 mg/kg. with rescue Tramadol-1mg/kg. 5 minutes before the commencement of subarachnoid blo

and then the postoperative period (4 hours).

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: (i) ASA grade I or II (ii) Patients of 18 -70 years age group (iii) Either sex

Exclusion criteria

Exclusion criteria: Following patients will be excluded from the study, (i) ASA grade III & IV (ii) Patients requiring administration of blood or blood products during surgery. (iii) All patients with contraindications for spinal anaesthesia like patient refusal; infection at the site of injection; severe, uncorrected hypovolemia; true allergy to any of the drugs; and increased intracranial pressure, except in cases of pseudo–tumor cerebri (idiopathic intracranial hypertension). (iv) Known hypersensitivity to tramadol and other allergies. (v) Known history of alcohol or substance abuse, (vi) Patient with fever & urinary tract infection (UTI).

Design outcomes

Primary

Measure	Time frame
Patients who develops either grade 2, grade 3 or grade 4 of shivering will be recorded in the study.Timepoint: From the administration of Spinal Anaesthesia (Sub Arachnoid Block) up to 4 hour post-operative period.	—

Secondary

Measure	Time frame
Adverse effects of two doses of tramadol are recorded & will be compared. Headaches nausea, vomiting and dizziness, feeling confused, feel very sleepy will be recorded will be compared between two doses of Intravenous TramadolTimepoint: From the administration of Spinal Anaesthesia (Sub Arachnoid Block) up to 4 hours postoperative period.	—

Countries

India

Contacts

Public ContactDR RATAN SASMAL

IQ CITY MEDICAL COLLEGE HOSPITAL

susmita782@yahoo.co.in9434235716

Outcome results

None listed

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