BradycardiaPhase 2NCT02676011
Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery
A Phase 2 study testing IM atropine, IV atropine and Atropine mixed with second dose succinylcholine in people with Bradycardia, run by Assiut University at 1 site in Egypt.
Trial summary
Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bradycardia
- What is being tested?
- IM atropine, IV atropine and Atropine mixed with second dose succinylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to May 2016
- Phase
- Phase 2
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients 18-50 years scheduled for elective diagnostic gynecological laparoscopic surgery
Who cannot join
- Cardiac
- Diabetes Mellitus
- Thyroid disease
- Any endocrine disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Brad Arrhythmia Induced by Repeated Succinylcholine by Atropine Sulfate During Gynecological Laparoscopic Surgery: a Randomized Controlled Trial
Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.
Read the detailed description
120 candidates, ASA 1 in the age range 18-40 years scheduled for elective diagnostic gynecological laparoscopic surgery were randomly assigned into 4 groups to receive either atropine sulfate or normal saline solution (as placebo).
- Conditions
- Bradycardia
- Being tested
- IM atropine, IV atropine, Atropine mixed with second dose succinylcholine, IM normal saline, IV normal saline
- Keywords
- Atropine, Succinycholine, Laparoscopy, Gynecology
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM atropineDrug
Also called IM atropine sulphate
Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia
IV atropineDrug
Also called IV atropine sulphate
Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia
Atropine mixed with second dose succinylcholineDrug
Also called atropine sulphate with succinylcholine
Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline
IM normal salineDrug
Also called Normal saline
1 ml normal saline IM 30 minutes before induction of anesthesia
IV normal salineDrug
Also called Normal saline
IV 10 ml normal saline 3 minutes before induction of anesthesia
Normal saline mixed with second dose succinylcholineDrug
Also called Normal saline with succinylcholine
Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Intramuscular (IM) atropine (0.01 mg/kg) (1 ml) 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline Receives: Drug: IM atropine; Drug: IV normal saline; Drug: Normal saline mixed with second dose succinylcholine |
| Group B | Active comparator | 1 ml normal saline IM 30 minutes before induction of anesthesia, intravenously (IV) atropine (0.01 mg/kg) in 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline Receives: Drug: IV atropine; Drug: IM normal saline; Drug: Normal saline mixed with second dose succinylcholine |
| Group C | Active comparator | IM normal saline 1 ml normal 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and 1mg/kg atropine mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline Receives: Drug: Atropine mixed with second dose succinylcholine; Drug: IM normal saline; Drug: IV normal saline |
| Group D | Placebo comparator | IM normal saline 1 ml normal 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline Receives: Drug: IM normal saline; Drug: IV normal saline; Drug: Normal saline mixed with second dose succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of bradycardia
heart rate less than 60 per minutes or decrease more than 30% of baseline reading
Measured: within the first 2 hours during surgery
Secondary outcomes (1)
Nasopharyngeal secretion
suction of Nasopharyngeal secretion (ml) during and after extubation
Measured: within the first 4 hours during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, M, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676011
- Sponsor's protocol ID
- IRB000087133
- Status last verified
- Sep 2016
- First submitted
- 3 Feb 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Brad Arrhythmia Induced by Repeated Succinylcholine by Atropine Sulfate During Gynecological Laparoscopic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02676011
- Acronym / sponsor ID
- IRB000087133
- Conditions
- Bradycardia
- Keywords
- Atropine, Succinycholine, Laparoscopy, Gynecology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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.
Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.
Detailed description
120 candidates, ASA 1 in the age range 18-40 years scheduled for elective diagnostic gynecological laparoscopic surgery were randomly assigned into 4 groups to receive either atropine sulfate or normal saline solution (as placebo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: IM atropine, Drug: IV normal saline, Drug: Normal saline mixed with second dose succinylcholineIntramuscular (IM) atropine (0.01 mg/kg) (1 ml) 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline |
| Group B | Active comparator | Drug: IV atropine, Drug: IM normal saline, Drug: Normal saline mixed with second dose succinylcholine1 ml normal saline IM 30 minutes before induction of anesthesia, intravenously (IV) atropine (0.01 mg/kg) in 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline |
| Group C | Active comparator | Drug: Atropine mixed with second dose succinylcholine, Drug: IM normal saline, Drug: IV normal salineIM normal saline 1 ml normal 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and 1mg/kg atropine mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline |
| Group D | Placebo comparator | Drug: IM normal saline, Drug: IV normal saline, Drug: Normal saline mixed with second dose succinylcholineIM normal saline 1 ml normal 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients 18-50 years scheduled for elective diagnostic gynecological laparoscopic surgery
Key exclusion criteria (4 listed)
- Cardiac
- Diabetes Mellitus
- Thyroid disease
- Any endocrine disease
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 |
|---|---|---|
| IM atropineAlso: IM atropine sulphateAtropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia | Drug | Group A |
| IV atropineAlso: IV atropine sulphateAtropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia | Drug | Group B |
| Atropine mixed with second dose succinylcholineAlso: atropine sulphate with succinylcholineAtropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline | Drug | Group C |
| IM normal salineAlso: Normal saline1 ml normal saline IM 30 minutes before induction of anesthesia | Drug | Group B, Group C, Group D |
| IV normal salineAlso: Normal salineIV 10 ml normal saline 3 minutes before induction of anesthesia | Drug | Group A, Group C, Group D |
| Normal saline mixed with second dose succinylcholineAlso: Normal saline with succinylcholineSecond dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline | Drug | Group A, Group B, Group D |
Primary outcome
Occurrence of bradycardia
Time frame: within the first 2 hours during surgery
heart rate less than 60 per minutes or decrease more than 30% of baseline reading
1 secondary outcome
Nasopharyngeal secretion
Time frame: within the first 4 hours during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
sayed abd elshafy, M principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IM atropine, IV atropine and Atropine mixed with second dose succinylcholine in people with Bradycardia, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 27 Sep 2016. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of bradycardia (time frame: within the first 2 hours during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2016.