Clinical trial NCT03580889: Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries
Official title: Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lower Extremity Fracture
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 138
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure from base line will be measured and hypotension will be described and treated as in description section
timeFrame: From anesthesia to 2 hrs after completion of surgery
measure: Heart rate will be monitored and treated accordingly
timeFrame: Iv atropine or glycopyrrolate to 2 hrs after completion of surgery
Secondary outcomes:
measure: Incidence of Nausea and vomiting will be described and treated accordingly.
timeFrame: Initiation of spinal anesthesia to 2 hrs after surgery
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: Dr. BishnuPokharel
state: Sunsari
Study officials:
References:
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.
citation: Paul g. Barash clinical anesthesia 7th edition
citation: Panning B, Lehnhardt E, Mehler D. [Transient low frequency hearing loss following spinal anesthesia]. Anaesthesist. 1984 Dec;33(12):593-5. German.
citation: 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.
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. doi: 10.1097/00000542-199206000-00006.
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. doi: 10.1093/bja/46.9.631. No abstract available.
citation: 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.
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. doi: 10.1093/bja/72.3.267.
citation: Coe AJ, Revanas B. Is crystalloid preloading useful in spinal anaesthesia in the elderly? Anaesthesia. 1990 Mar;45(3):241-3. doi: 10.1111/j.1365-2044.1990.tb14696.x.
citation: 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.
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
citation: 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.