LaparoscopyNCT01992640
Recovery After Laparoscopic Surgery
An observational study of Laparoscopy, run by Herlev Hospital at 1 site in Denmark.
Trial summary
During laparoscopic surgery, muscle relaxants are often administrated in order to ensure acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopy
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to May 2014
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients scheduled for laparoscopic surgery at Herlev Hospital and expected discharge on the same day as surgery.
Who may be able to join
- Age above 18 years
- Same-day gynaecological laparoscopic surgery
- Informed consent
Who cannot join
- Body mass index above 30 kg/m2
- Insufficient renal function
- Liver insufficience
- Neuromuscular monitoring not possible
- Known allergy towards medicine used in the protocol
- Daily use of opioids
Show all 10Show fewer
- Known disease which can interfere with the balance
- Pregnant/lactating
- Cannot read or understand danish
- Fast-track intubation with use of succinylcholine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital
Herlev, 2730
About this study
During laparoscopic surgery, muscle relaxants are often administrated in order to ensure acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.
The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there may still be a blockade of up to 70% of the receptors.
Read more
This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged hospitalization.
This study will describe changes in balance and subjective muscle weakness after laparoscopic surgery.
The primary hypothesis is that sway area is increased 30 min after extubation compared to the preoperative value.
- Conditions
- Laparoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postural sway area 30 min after extubation (closed eyes)
Measured: Preoperatively and 30 min after extubation
Secondary outcomes (18)
Change in sway area when ready to be discharge form the postoperative care unit (PACU)(closed eyes)
Measured: Preoperatively and at discharge from the PACU. An expected duration of 2 hours after surgery
change in sway area 30 min after extubation (open eyes)
Measured: Preoperatively and 30 min after extubation
Change in sway area when ready to be discharged from the PACU (open eyes)
Measured: Preoperatively and when ready to be discharged from the PACU. An expected average of 2 hours after surgery
Change in sway velocity 30 min after extubation (closed eyes)
Measured: Preoperatively and 30 min after extubation
Change in sway velocity 30 min after extubation (open eyes)
Measured: Preoperatively and 30 min after extubation
Change in sway velocity when ready to be discharged from the PACU (closed eyes)
Measured: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in sway velocity when ready to be discharged from the PACU (open eyes)
Measured: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in mean sway 30 min after extubation (closed eyes)
Measured: Preoperatively and 30 min after extubation
Change in mean sway 30 min after extubation (open eyes)
Measured: Preoperatively and 30 min after extubation
Change in mean sway when ready to discharge from the PACU (closed eyes)
Measured: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery.
Change in mean sway when ready to be discharged from the PACU (open eyes)
Measured: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in subjective balance 30 min after extubation
Measured: Preoperatively and 30 min after extubation
Change in subjective balance when ready to be discharged from the PACU
Measured: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in muscle weakness 30 min after extubation
Measured: Preoperatively and 30 min after extubation
Change in muscle weakness when ready to be discharged from the PACU
Measured: preoperatively and when ready to be discharge from the PACU. An expected duration of 2 hours
Incidence of critical respiratory events from extubation until discharge from the PACU
Measured: From extubation until discharge from the PACU (approximately 2 hours)
Duration of stay at the PACU
Measured: The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours
Duration of postoperative hospitalization
Measured: The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kathrine Staehr-Rye, Herlev Hospital
- Investigators
- Anne K Staehr-Rye, M.D., Principal investigator, Dept. of Anesthesiology, Herlev HospitalMona R Gätke, M.D.; Ph.D., Study chair, Dept. of Anesthesiology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992640
- Sponsor's protocol ID
- 11-2013
- Status last verified
- Jun 2014
- First submitted
- 7 Nov 2013
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01992640
- Acronym / sponsor ID
- 11-2013
- Conditions
- Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Nov 2013 (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.
During laparoscopic surgery, muscle relaxants are often administrated in order to ensure acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.
The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there may still be a blockade of up to 70% of the receptors.
This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged hospitalization.
This study will describe changes in balance and subjective muscle weakness after laparoscopic surgery.
The primary hypothesis is that sway area is increased 30 min after extubation compared to the preoperative value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients scheduled for laparoscopic surgery at Herlev Hospital and expected discharge on the same day as surgery.
Key inclusion criteria (3 listed)
- Age above 18 years
- Same-day gynaecological laparoscopic surgery
- Informed consent
Key exclusion criteria (10 listed)
- Body mass index above 30 kg/m2
- Insufficient renal function
- Liver insufficience
- Neuromuscular monitoring not possible
- Known allergy towards medicine used in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in postural sway area 30 min after extubation (closed eyes)
Time frame: Preoperatively and 30 min after extubation
18 secondary outcomes
Change in sway area when ready to be discharge form the postoperative care unit (PACU)(closed eyes)
Time frame: Preoperatively and at discharge from the PACU. An expected duration of 2 hours after surgery
change in sway area 30 min after extubation (open eyes)
Time frame: Preoperatively and 30 min after extubation
Change in sway area when ready to be discharged from the PACU (open eyes)
Time frame: Preoperatively and when ready to be discharged from the PACU. An expected average of 2 hours after surgery
Change in sway velocity 30 min after extubation (closed eyes)
Time frame: Preoperatively and 30 min after extubation
Change in sway velocity 30 min after extubation (open eyes)
Time frame: Preoperatively and 30 min after extubation
Change in sway velocity when ready to be discharged from the PACU (closed eyes)
Time frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in sway velocity when ready to be discharged from the PACU (open eyes)
Time frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in mean sway 30 min after extubation (closed eyes)
Time frame: Preoperatively and 30 min after extubation
Change in mean sway 30 min after extubation (open eyes)
Time frame: Preoperatively and 30 min after extubation
Change in mean sway when ready to discharge from the PACU (closed eyes)
Time frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery.
Change in mean sway when ready to be discharged from the PACU (open eyes)
Time frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in subjective balance 30 min after extubation
Time frame: Preoperatively and 30 min after extubation
Change in subjective balance when ready to be discharged from the PACU
Time frame: Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery
Change in muscle weakness 30 min after extubation
Time frame: Preoperatively and 30 min after extubation
Change in muscle weakness when ready to be discharged from the PACU
Time frame: preoperatively and when ready to be discharge from the PACU. An expected duration of 2 hours
Incidence of critical respiratory events from extubation until discharge from the PACU
Time frame: From extubation until discharge from the PACU (approximately 2 hours)
Duration of stay at the PACU
Time frame: The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours
Duration of postoperative hospitalization
Time frame: The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours
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 20 Jun 2014.
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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.
Anne K Staehr-Rye, M.D. principal investigator
Dept. of Anesthesiology, Herlev Hospital
Mona R Gätke, M.D.; Ph.D. study chair
Dept. of Anesthesiology, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopy, run by Herlev Hospital at 1 site in Denmark.
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 3 inclusion and 10 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 20 Jun 2014. 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 Denmark. 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.
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?
Change in postural sway area 30 min after extubation (closed eyes) (time frame: Preoperatively and 30 min after extubation). 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 20 Jun 2014.