Laparoscopic SurgeryPhase 4ALGOSNCT02769325
Atropine in Laparoscopic Gynaecological Surgery
A Phase 4 study testing Atropine, Sevoflurane and sugammadex in people with Laparoscopic Surgery and Gynecology, run by Clinica Santa Maria at 1 site in Chile.
Trial summary
This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Laparoscopic Surgery, Gynecology
- What is being tested?
- Atropine, Sevoflurane and sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- May 2016to Aug 2017
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI <35
Who cannot join
- Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial
This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery
Read the detailed description
Patients that meet eligibility criteria will receive a standardised general anesthesia based on sevoflurane and opioids and will be randomised in two groups, using computer generated randomisation system. Allocation concealment is established on opaque envelopes that contain random allocation.
Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will be administered.
At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study.
Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care unit (PACU) and 24 postoperative hours by an investigator blinded to study group
- Conditions
- Laparoscopic Surgery, Gynecology
- Being tested
- Atropine, Placebo, Sevoflurane, sugammadex, Ketorolac
- Keywords
- atropine, pain, postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
IV atropine 0.1%, 10 ml
PlaceboDrug
IV saline, 10 ml
SevofluraneDrug
All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
sugammadexDrug
Patients will receive sugamadex for neuromuscular reversion, if necessary
KetorolacDrug
60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
Morphine PCADrug
Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
rocuroniumDrug
general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
propofolDrug
for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol
| Study group | Role | What they receive |
|---|---|---|
| Atropine | Experimental | Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia Receives: Drug: Atropine; Drug: Sevoflurane; Drug: sugammadex; Drug: Ketorolac; Drug: Morphine PCA; Drug: rocuronium; Drug: propofol |
| placebo | Placebo comparator | Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia Receives: Drug: Placebo; Drug: Sevoflurane; Drug: sugammadex; Drug: Ketorolac; Drug: Morphine PCA; Drug: rocuronium; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours morphine consumption
morphine consumption, measured 24 post hours, in mg
Measured: 24 hours
Secondary outcomes (7)
Pain Visual analog scale at 24 hours
Measured: 24 hours
pain visual analog scale at postanesthesia care unit
Measured: 2 hours post
number of patients with postoperative nausea and/or vomiting
Measured: 24 hours
Patient satisfaction, on a qualitative scale
Measured: up to three days
number of patients that refer palpitations
Measured: 24 hours
number of patients that refer mouth dryness
Measured: 24 hours
number of patients that refer blurred vision
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Torres, Clinica Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769325
- Sponsor's protocol ID
- CSM2016001
- Acronym
- ALGOS
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02769325
- Acronym / sponsor ID
- ALGOS / CSM2016001
- Conditions
- Laparoscopic Surgery, Gynecology
- Keywords
- atropine, pain, postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinica Santa MariaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 11 May 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.
This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery
Detailed description
Patients that meet eligibility criteria will receive a standardised general anesthesia based on sevoflurane and opioids and will be randomised in two groups, using computer generated randomisation system. Allocation concealment is established on opaque envelopes that contain random allocation.
Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will be administered.
At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study.
Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care unit (PACU) and 24 postoperative hours by an investigator blinded to study group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine | Experimental | Drug: Atropine, Drug: Sevoflurane, Drug: sugammadex, Drug: Ketorolac, Drug: Morphine PCA, Drug: rocuronium, Drug: propofolPatients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia |
| placebo | Placebo comparator | Drug: Placebo, Drug: Sevoflurane, Drug: sugammadex, Drug: Ketorolac, Drug: Morphine PCA, Drug: rocuronium, Drug: propofolPatients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI <35
Key exclusion criteria (1 listed)
- Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers
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 |
|---|---|---|
| AtropineIV atropine 0.1%, 10 ml | Drug | Atropine |
| PlaceboIV saline, 10 ml | Drug | placebo |
| SevofluraneAll patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60 | Drug | Atropine, placebo |
| sugammadexPatients will receive sugamadex for neuromuscular reversion, if necessary | Drug | Atropine, placebo |
| Ketorolac60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period | Drug | Atropine, placebo |
| Morphine PCAPatients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout | Drug | Atropine, placebo |
| rocuroniumgeneral anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation | Drug | Atropine, placebo |
| propofolfor anaesthesia induction, patients will receive 2-3 mg/kg iv propofol | Drug | Atropine, placebo |
Primary outcome
24 hours morphine consumption
Time frame: 24 hours
morphine consumption, measured 24 post hours, in mg
7 secondary outcomes
Pain Visual analog scale at 24 hours
Time frame: 24 hours
pain visual analog scale at postanesthesia care unit
Time frame: 2 hours post
number of patients with postoperative nausea and/or vomiting
Time frame: 24 hours
Patient satisfaction, on a qualitative scale
Time frame: up to three days
number of patients that refer palpitations
Time frame: 24 hours
number of patients that refer mouth dryness
Time frame: 24 hours
number of patients that refer blurred vision
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Surgery
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
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.
The record lists no contact. Use the official record to reach the sponsor.
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, Sevoflurane and sugammadex in people with Laparoscopic Surgery and Gynecology, run by Clinica Santa Maria at 1 site in Chile.
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 1 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 11 May 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 Chile. 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 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?
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?
24 hours morphine consumption (time frame: 24 hours). 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 11 May 2016.