A study to compare the effects of ondansetron and glycopyrrolate to prevent the fall in blood pressure and heart rate following spinal anaesthesia in patients undergoing lower limb orthopaedic surgery

Phase 3

Not yet recruiting

Conditions: Pathological fracture, not elsewhere classified, (2) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified,

Registration Number: CTRI/2022/05/042507

Lead Sponsor: Caicutta National Medical College And Hospital

Brief Summary: This prospective, parallel group, double blind placebo-controlledstudy will be conducted on 123patients of age 18-45 years, either sex, ASA physical status I & IIundergoing elective lower limb orthopaedic surgeries under spinal anaesthesia.Patients will be randomly divided into 3 groups, Group OGroup G and Group N. Patients inGroup O will receive inj. ondansetron 4 mg(2 ml) IV, patients in Group Gwill receive inj. glycopyrrolate 0.2 mg(2 ml) IV and patients in Group N will receive normal saline 2 ml IV, 5 minutesprior to spinal anaesthesia. Heart rate, blood pressure, phenylephrine andintravenous fluid requirement will be recorded intraoperatively andpostoperatively. The study will be conducted to compare ondansetron and glycopyrrolate in prevention of spinal induced hypotension and bradycardia in patients undergoing lower limb orthopaedic surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 123

Inclusion Criteria

Patients of age 18-45 years, either sex, ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia will be included in this study.

Exclusion Criteria

Exclusion criteria: (i) Patients having contraindications for spinal anaesthesia like lack of consent, raised intra cranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability.
(ii) Patients with known allergy to study drugs (iii) Patients with BMI > 30 kg/mÂ² (iv) Patients having height < 150 cm (v) Patients ASA physical status III or more (vi) Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine diseases.
(vii) Patients with glaucoma (viii) Patients receiving any antihypertensive, vasodilator, antiarrhythmic or antiemetic agents (ix) Patients requiring general anaesthesia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of hypotension intraoperatively after giving spinal anaesthesia	19 months

Secondary Outcome Measures

Name	Time	Method
incidence of bradycardia, total phenylephrine requirement and total fluid requirement in the intraoperative period.	19 months

Trial Locations

Locations (1): Calcutta national medical college and hospital
🇮🇳
Kolkata, WEST BENGAL, India
Calcutta national medical college and hospital
🇮🇳Kolkata, WEST BENGAL, India
DrPalas Halder
Principal investigator
7003669074
dr.palas@gmail.com