Recovery After Laparoscopic Surgery

Completed

• Conditions: Laparoscopy

• Registration Number: NCT01992640
• Lead Sponsor: Herlev Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Study Start: 2013-12
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in postural sway area 30 min after extubation (closed eyes)	Preoperatively and 30 min after extubation

Secondary Outcome Measures

Name	Time	Method
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
Change in sway velocity 30 min after extubation (closed eyes)	Preoperatively and 30 min after extubation
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
Change in mean sway 30 min after extubation (closed eyes)	Preoperatively and 30 min after extubation
Change in subjective balance 30 min after extubation	Preoperatively and 30 min after extubation
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
change in sway area 30 min after extubation (open eyes)	Preoperatively and 30 min after extubation
Change in sway velocity 30 min after extubation (open eyes)	Preoperatively and 30 min after extubation
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
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
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
Duration of postoperative hospitalization	The patient will be followed from extubation until discharge from hospital. An expected average duration of 12 hours
Change in mean sway 30 min after extubation (open eyes)	Preoperatively and 30 min after extubation
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.
Change in muscle weakness 30 min after extubation	Preoperatively and 30 min after extubation
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
Incidence of critical respiratory events from extubation until discharge from the PACU	From extubation until discharge from the PACU (approximately 2 hours)
Duration of stay at the PACU	The patients will be followed from extubation until leaving the PACU. An expected average duration of 2 hours

Trial Locations

Locations (1)

Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital; 🇩🇰 Herlev, Denmark