Recovery After Laparoscopic Surgery

Laparoscopy Clinical Trial

Official title:

Recovery After Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992640
• Other study ID #: 11-2013
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: June 18, 2014
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years

• Same-day gynaecological laparoscopic surgery

• Informed consent

Exclusion Criteria:

• 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

• Known disease which can interfere with the balance

• Pregnant/lactating

• Cannot read or understand danish

• Fast-track intubation with use of succinylcholine

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laparoscopy

Locations

Country	Name	City	State
Denmark	Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postural sway area 30 min after extubation (closed eyes)		Preoperatively and 30 min after extubation	No
Secondary	Change in sway area when ready to be discharge form the postoperative care unit (PACU)(closed eyes)		Preoperatively and at discharge from the PACU. An expected duration of 2 hours after surgery	No
Secondary	change in sway area 30 min after extubation (open eyes)		Preoperatively and 30 min after extubation	No
Secondary	Change in sway area when ready to be discharged from the PACU (open eyes)		Preoperatively and when ready to be discharged from the PACU. An expected average of 2 hours after surgery	No
Secondary	Change in sway velocity 30 min after extubation (closed eyes)		Preoperatively and 30 min after extubation	No
Secondary	Change in sway velocity 30 min after extubation (open eyes)		Preoperatively and 30 min after extubation	No
Secondary	Change in sway velocity when ready to be discharged from the PACU (closed eyes)		Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery	No
Secondary	Change in sway velocity when ready to be discharged from the PACU (open eyes)		Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery	No
Secondary	Change in mean sway 30 min after extubation (closed eyes)		Preoperatively and 30 min after extubation	No
Secondary	Change in mean sway 30 min after extubation (open eyes)		Preoperatively and 30 min after extubation	No
Secondary	Change in mean sway when ready to discharge from the PACU (closed eyes)		Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery.	No
Secondary	Change in mean sway when ready to be discharged from the PACU (open eyes)		Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery	No
Secondary	Change in subjective balance 30 min after extubation		Preoperatively and 30 min after extubation	No
Secondary	Change in subjective balance when ready to be discharged from the PACU		Preoperatively and when ready to be discharged from the PACU. An expected duration of 2 hours after surgery	No
Secondary	Change in muscle weakness 30 min after extubation		Preoperatively and 30 min after extubation	No
Secondary	Change in muscle weakness when ready to be discharged from the PACU		preoperatively and when ready to be discharge from the PACU. An expected duration of 2 hours	No
Secondary	Incidence of critical respiratory events from extubation until discharge from the PACU		From extubation until discharge from the PACU (approximately 2 hours)	No
Secondary	Duration of stay at the PACU		The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours	No
Secondary	Duration of postoperative hospitalization		The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours	No