Recovery After Laparoscopic Surgery

NCT01992640 | Completed

• 1 other identifier: 11-2013
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Change in postural sway area 30 min after extubation (closed eyes)

  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)

  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 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 sway velocity 30 min after extubation (closed eyes)

  Preoperatively and 30 min after extubation

• Change in sway velocity 30 min after extubation (open eyes)

  Preoperatively and 30 min after extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients scheduled for laparoscopic surgery at Herlev Hospital and expected discharge on the same day as surgery.

You may qualify if:

• Age above 18 years
• Same-day gynaecological laparoscopic surgery
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Dept. of Anesthesiology, University of Copenhagen, Herlev Hospital

Herlev, 2730, Denmark

Location

Study Officials

• Anne K Staehr-Rye, M.D.

  Dept. of Anesthesiology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

• Mona R Gätke, M.D.; Ph.D.

  Dept. of Anesthesiology, Herlev Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

DK (1)