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

Lower Extremity Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03580889
• Other study ID #: IRC/1087/017
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2017
• Est. completion date: September 2018

Study information

• Verified date: August 2018
• Source: B.P. Koirala Institute of Health Sciences
• Contact: Bishnu Pokharel, Dr.
• Phone: 025525555
• Email: Bpkihs[@]bpkihs.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Lower Extremity Fracture

Intervention

Drug:
• Atropine
Comparison between atropine, glycopyrrolate and Normal Saline
• Glycopyrrolate
Comparison between glycopyrrolate, atropine and Normal saline
• Normal Saline Flush, 0.9% Injectable Solution
Comparison between Normal saline, atropine and glycopyrrolate

Locations

Country	Name	City	State
Nepal	Dr. BishnuPokharel	Dharan Bazar	Sunsari

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (12)

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. — View Citation

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. — View Citation

Coe AJ, Revanäs B. Is crystalloid preloading useful in spinal anaesthesia in the elderly? Anaesthesia. 1990 Mar;45(3):241-3. — View Citation

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. — View Citation

Duncan CM, Hall Long K, Warner DO, Hebl JR. The economic implications of a multimodal analgesic regimen for patients undergoing major orthopedic surgery: a comparative study of direct costs. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):301-7. doi: 10.1097/AAP.0b013e3181ac7f86. — View Citation

McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. Review. — View Citation

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. — View Citation

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

Paul g. Barash clinical anesthesia 7th edition

Reiz S, Nath S, Pontén E, Friedman A, Bäcklund 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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of Nausea and vomiting will be described and treated accordingly.	0- no nausea no vomiting; light nausea and no vomiting; moderate nausea one or two vomiting episodes; severe nausea, 3 or more vomiting episodes	Initiation of spinal anesthesia to 2 hrs after surgery