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

Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03580889

Enrollment

138

Registered

2018-07-10

Start date

2017-09-15

Completion date

2018-09-30

Last updated

2018-08-16

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

Conditions

Lower Extremity Fracture

Brief summary

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.

Interventions

DRUGAtropine

Comparison between atropine, glycopyrrolate and Normal Saline

DRUGGlycopyrrolate

Comparison between glycopyrrolate, atropine and Normal saline

DRUGNormal Saline Flush, 0.9% Injectable Solution

Comparison between Normal saline, atropine and glycopyrrolate

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure from base line will be measured and hypotension will be described and treated as in description section	From anesthesia to 2 hrs after completion of surgery	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
Heart rate will be monitored and treated accordingly	Iv atropine or glycopyrrolate to 2 hrs after completion of surgery	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

Secondary

Measure	Time frame	Description
Incidence of Nausea and vomiting will be described and treated accordingly.	Initiation of spinal anesthesia to 2 hrs after surgery	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

Countries

Nepal

Contacts

Primary ContactBishnu Pokharel, Dr.

Bpkihs@bpkihs.edu025525555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026