Lower Extremity FracturePhase 4NCT03580889
Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries
A Phase 4 study testing Atropine, Glycopyrrolate and Normal Saline Flush, 0.9% Injectable Solution in people with Lower Extremity Fracture, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- Atropine, Glycopyrrolate and Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteNepal
- Study dates
- 15 Sep 2017to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA PS I and II,
- age 16 to 65,
- undergoing lower limb major orthopedic surgery,
- willing to participate
Who cannot join
- Contra indication to spinal anesthesia,
- patient refusal,
- ASA PS >III,
- cardiac diseases,
- hypertension >160/ 100,
- arrhythmias,
Show all 9Show fewer
- Acute coronary syndrome,
- patients taking beta-blockers,
- hepatic and pulmonary diseases
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
Dr. BishnuPokharel
Dharān, Sunsari, 977
Bishnu Pokharel, Dr., 025525555, Bpkihs@bpkihs.edu
Raju Thapamagar, Dr
About this study
Official title: Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
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
- Being tested
- Atropine, Glycopyrrolate, Normal Saline Flush, 0.9% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Comparison between atropine, glycopyrrolate and Normal Saline
GlycopyrrolateDrug
Comparison between glycopyrrolate, atropine and Normal saline
Normal Saline Flush, 0.9% Injectable SolutionDrug
Also called Normal Saline
Comparison between Normal saline, atropine and glycopyrrolate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
0- no nausea no vomiting
- light nausea and no vomiting
- moderate nausea one or two vomiting episodes
- severe nausea, 3 or more vomiting episodes
Measured: Initiation of spinal anesthesia to 2 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start15 Sep 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raju Thapamagar, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580889
- Sponsor's protocol ID
- IRC/1087/017
- Status last verified
- Aug 2018
- First submitted
- 17 Jun 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to share IPD with other investigators
Publications
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.
PubMed 19574862Paul g. Barash clinical anesthesia 7th edition
Panning B, Lehnhardt E, Mehler D. [Transient low frequency hearing loss following spinal anesthesia]. Anaesthesist. 1984 Dec;33(12):593-5. German.
PubMed 6528963Buvanendran 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.
PubMed 12198056Carpenter 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.
PubMed 1599111Morikawa 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.
PubMed 4621170Reiz 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.
PubMed 43650Dobson 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.
PubMed 8130043Coe 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.
PubMed 2334037McCrae 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.
PubMed 8329261Sigdel 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. doi: 10.1097/00000542-200007000-00021.
PubMed 10861154
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT03580889
- Acronym / sponsor ID
- IRC/1087/017
- Conditions
- Lower Extremity Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atropine sulphate | Active comparator | Drug: AtropineAtropine 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 | Drug: GlycopyrrolateGlycopyrrolate 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 | Drug: Normal Saline Flush, 0.9% Injectable SolutionNormal 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ASA PS I and II,
- age 16 to 65,
- undergoing lower limb major orthopedic surgery,
- willing to participate
Key exclusion criteria (9 listed)
- Contra indication to spinal anesthesia,
- patient refusal,
- ASA PS >III,
- cardiac diseases,
- hypertension >160/ 100,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineComparison between atropine, glycopyrrolate and Normal Saline | Drug | Atropine sulphate |
| GlycopyrrolateComparison between glycopyrrolate, atropine and Normal saline | Drug | Glycopyrrolate |
| Normal Saline Flush, 0.9% Injectable SolutionAlso: Normal SalineComparison between Normal saline, atropine and glycopyrrolate | Drug | Normal Saline |
Primary outcome
Blood pressure from base line will be measured and hypotension will be described and treated as in description section
Time frame: 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
Time frame: 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
1 secondary outcome
Incidence of Nausea and vomiting will be described and treated accordingly.
Time frame: Initiation of spinal anesthesia to 2 hrs after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 19574862Duncan 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.
- BackgroundPaul g. Barash clinical anesthesia 7th edition
- Background: PubMed 6528963Panning B, Lehnhardt E, Mehler D. [Transient low frequency hearing loss following spinal anesthesia]. Anaesthesist. 1984 Dec;33(12):593-5. German.
- Background: PubMed 12198056Buvanendran 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.
- Background: PubMed 1599111Carpenter 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.
- Background: PubMed 4621170Morikawa 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.
- Background: PubMed 43650Reiz 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.
- Background: PubMed 8130043Dobson 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.
- Background: PubMed 2334037Coe 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.
- Background: PubMed 8329261McCrae 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.
- BackgroundSigdel 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
- Results publication: PubMed 10861154Stevens 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.
- Individual participant dataSharing planned: No. I do not want to share IPD with other investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine, Glycopyrrolate and Normal Saline Flush, 0.9% Injectable Solution in people with Lower Extremity Fracture, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bishnu Pokharel, Dr. (025525555, Bpkihs@bpkihs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure from base line will be measured and hypotension will be described and treated as in description section (time frame: From anesthesia to 2 hrs after completion of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580889, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.