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

NCT03580889 | Unknown Phase 4 DMC

• 1 other identifier: IRC/1087/017
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Fracture

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Iv atropine or glycopyrrolate to 2 hrs after completion of surgery

Secondary Outcomes (1)

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

  Initiation of spinal anesthesia to 2 hrs after surgery

Study Arms (3)

Atropine sulphate

ACTIVE COMPARATOR

Atropine 5 mcg/kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blood pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly

Drug: Atropine

Glycopyrrolate

ACTIVE COMPARATOR

Glycopyrrolate 2.5 mcg / kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly.

Drug: Glycopyrrolate

Normal Saline

ACTIVE COMPARATOR

Normal saline 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly.

Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

Atropine DRUG

Comparison between atropine, glycopyrrolate and Normal Saline

Atropine sulphate

Glycopyrrolate DRUG

Comparison between glycopyrrolate, atropine and Normal saline

Glycopyrrolate

Normal Saline Flush, 0.9% Injectable Solution DRUG

Comparison between Normal saline, atropine and glycopyrrolate

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS I and II,
• age 16 to 65,
• undergoing lower limb major orthopedic surgery,
• willing to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Dr. BishnuPokharel

Dharān, Sunsari, 977, Nepal

RECRUITING

Related Publications (12)

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  PMID: 19574862 BACKGROUND

• Paul g. Barash clinical anesthesia 7th edition

  BACKGROUND

• Panning B, Lehnhardt E, Mehler D. [Transient low frequency hearing loss following spinal anesthesia]. Anaesthesist. 1984 Dec;33(12):593-5. German.

  PMID: 6528963 BACKGROUND

• Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031.

  PMID: 12198056 BACKGROUND

• Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.

  PMID: 1599111 BACKGROUND

• Morikawa KI, Bonica JJ, Tucker GT, Murphy TM. Effect of acute hypovolaemia on lignocaine absorption and cardiovascular response following epidural block in dogs. Br J Anaesth. 1974 Sep;46(9):631-5. doi: 10.1093/bja/46.9.631. No abstract available.

  PMID: 4621170 BACKGROUND

• Reiz S, Nath S, Ponten E, Friedman A, Backlund U, Olsson B, Rais O. Effects of thoracic epidural block and the beta-1-adrenoreceptor agonist prenalterol on the cardiovascular response to infrarenal aortic cross-clamping in man. Acta Anaesthesiol Scand. 1979 Oct;23(5):395-403. doi: 10.1111/j.1399-6576.1979.tb01466.x.

  PMID: 43650 BACKGROUND

• Dobson PM, Caldicott LD, Gerrish SP, Cole JR, Channer KS. Changes in haemodynamic variables during transurethral resection of the prostate: comparison of general and spinal anaesthesia. Br J Anaesth. 1994 Mar;72(3):267-71. doi: 10.1093/bja/72.3.267.

  PMID: 8130043 BACKGROUND

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  PMID: 2334037 BACKGROUND

• McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.

  PMID: 8329261 BACKGROUND

• Sigdel S. Prophylactic use of iv atropine for prevention of spinal anesthesia induced hypotension and bradycardia in elderly. A randomized controlled trial. J anesthesiol clin res.2015;4(1):5

  BACKGROUND

• Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.

  PMID: 10861154 RESULT

MeSH Terms

Interventions

Atropine; Glycopyrrolate; Saline Solution

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quaternary Ammonium Compounds; Amines; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Bishnu Pokharel, Dr.

CONTACT

025525555; Bpkihs@bpkihs.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 17, 2018
• First Posted: July 10, 2018
• Study Start: September 15, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)