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Use of oral tizanidine in laparoscopic abdominal surgeries

PRE-EMPTIVE USE OF ORAL TIZANIDINE IN LAPAROSCOPIC ABDOMINAL SURGERIES : A PROSPECTIVE RANDOMIZED PLACEBO CONTROLLED DOUBLE BLIND STUDY - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055621
Enrollment
60
Registered
2023-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: N719- Inflammatory disease of uterus, unspecified Health Condition 3: K358- Other and unspecified acute appendicitis

Interventions

Intervention1: Tizanadine: 6mg oral, 60-90 mins before surgery BASELINE MAP AND HR WILL BE MONITORED BEFORE INITIATION OF SURGERY, THEN EVERY 5 MINS UNTIL PNEUMOPERITONEUM, THEREAFTER EVERY 15 MINS UN

Sponsors

Fortis Escorts Hospital Faridabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-60 years 2.ASA status I and II 3.BMI less than 35

Exclusion criteria

Exclusion criteria: 1. ASA status more than II 2.BMI more than 35 3. Laparoscopic hernia repair surgeries 4.Emergency cases 5. Allergy to tizanidine 6. History of alcohol consumption 7. Patients on treatment with beta-blockers, digoxin, anticonvulsants, antihypertensive drugs, sedatives or α2 agonists 8. CNS disorders 9. Renal or hepatic insufficiency 10. Peptic ulcer 11. Hypertension 12. Patients with chronic pain 13. Bleeding disorders 14. Sleep disturbances

Design outcomes

Primary

MeasureTime frame
The total dose of fentanyl consumed intra-operatively will be noted.Timepoint: 60-128mins

Secondary

MeasureTime frame
â?¢ Post-operative pain will be evaluated using VAS on arrival in PACU, at 2 h, 6 h, 12 h after surgery. â?¢ The time for the first request for rescue analgesia will be noted. â?¢ Incidence of side effects such as headache, dry mouth, dizziness, nausea, vomiting & bradycardia will be noted.Timepoint: 1. POST OP PAIN SCORES AT ARRIVAL AT PACU, 2HR, 6HR, 12HR 2. INCIDENCE OF SIDE EFFECTS AT ARRIVAL AT PACU

Countries

India

Contacts

Public ContactDr Anupom Maria

Fortis escorts Hospital

anupom.maria@fortishealthcare.com9650982591

Outcome results

None listed

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