Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries

B.P. Koirala Institute of Health Sciences138 enrolled

Overview

A study to compare between intravenous atropine and glycopyrrolate in preventing spinal anesthesia induced hypotension in patients undergoing major lower limb orthopedic surgeries. Hypotension is the most common complication in spinal anesthesia that can be life threatening. If this can be prevented patients comfort can be increased and satisfaction as well.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

138

Conditions

Lower Extremity Fracture

Interventions

AtropineDRUG

Comparison between atropine, glycopyrrolate and Normal Saline

GlycopyrrolateDRUG

Comparison between glycopyrrolate, atropine and Normal saline

Normal Saline Flush, 0.9% Injectable SolutionDRUG

Comparison between Normal saline, atropine and glycopyrrolate

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ASA PS I and II, * age 16 to 65, * undergoing lower limb major orthopedic surgery, * willing to participate Exclusion Criteria: * Contra indication to spinal anesthesia, * patient refusal, * ASA PS \>III, * cardiac diseases, * hypertension \>160/ 100, * arrhythmias, * Acute coronary syndrome, * patients taking beta-blockers, * hepatic and pulmonary diseases

Locations (1)

Dr. BishnuPokharel

Dharān, Sunsari, Nepal

RECRUITING

Outcomes

Primary Outcomes

Blood pressure from base line will be measured and hypotension will be described and treated as in description section

Systolic arterial pressure \<90 mm of hg or 20% decrease from base line or decrease in blood pressure 30 mm Hg or more from base line will be considered hypotension. Hypotension along with tachycardia (as described below) will be treated with phenylephrine 100 mcg and hypotension alone will be treated with mephentermine 6 mg bolus

Time frame: From anesthesia to 2 hrs after completion of surgery

Heart rate will be monitored and treated accordingly

Heart rate \> 100 Bpm or more or more than 20% from base line will be described as tachycardia. Heart rate less than 50 bpm or less than 20% from baseline will be described as bradycardia

Time frame: Iv atropine or glycopyrrolate to 2 hrs after completion of surgery

Secondary Outcomes

Incidence of Nausea and vomiting will be described and treated accordingly.

0- no nausea no vomiting 1. light nausea and no vomiting 2. moderate nausea one or two vomiting episodes 3. severe nausea, 3 or more vomiting episodes

Time frame: Initiation of spinal anesthesia to 2 hrs after surgery

Central Contacts

Bishnu Pokharel, Dr.

CONTACT

025525555 Bpkihs@bpkihs.edu

Data from ClinicalTrials.gov

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