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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | Comparison between atropine, glycopyrrolate and Normal Saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea and vomiting will be described and treated accordingly. | 0- no nausea no vomiting
| Initiation of spinal anesthesia to 2 hrs after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bishnu Pokharel, Dr. | Contact | 025525555 | Bpkihs@bpkihs.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. BishnuPokharel | Recruiting | Dharān | Sunsari | 977 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19574862 | Background | 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. | |
| Background | Paul g. Barash clinical anesthesia 7th edition | ||
| 6528963 |
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I do not want to share IPD with other investigators
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| ID | Term |
|---|---|
| D001285 | Atropine |
| D006024 | Glycopyrrolate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Glycopyrrolate |
| Drug |
Comparison between glycopyrrolate, atropine and Normal saline |
|
| Normal Saline Flush, 0.9% Injectable Solution | Drug | Comparison between Normal saline, atropine and glycopyrrolate |
|
|
| Background |
| Panning B, Lehnhardt E, Mehler D. [Transient low frequency hearing loss following spinal anesthesia]. Anaesthesist. 1984 Dec;33(12):593-5. German. |
| 12198056 | 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. |
| 1599111 | 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. |
| 4621170 | 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. |
| 43650 | 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. |
| 8130043 | 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. |
| 2334037 | Background | 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. |
| 8329261 | 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. |
| 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 |
| 10861154 | Result | 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. |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |