Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorZagazig University
About this trial
Ambulatory surgery places high demands on anesthetic technique. rapid onset and offset of anesthesia, rapid recovery of protective reflexes, mobility and micturition, are required. Since the inception of ambulatory surgery, the favored anesthetic technique has been general anesthesia with short-acting drugs. Concerns about the time to perform spinal anesthesia and the risks of prolonged motor block and urinary retention have limited its use.
Alpha-blockers, lavage fluids for epidural space, insulin, and intravenous lipid emulsions, are still being discussed to shorten and reverse adverse effect of different LAs used for spinal anaesthesia, hence we will evaluate the effectiveness of intravenous lipid emulsion for reversing the neural blockade of spinal anaesthesia in patients undergoing ambulatory surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient acceptance.
Cooperative patient
Age 21-70 years old.
BMI ≤ 35 kg/m2
Disqualifiers
History of allergy to the LA agents used in this study,
Skin lesion at needle insertion site,
Those with bleeding disorders, sepsis, liver disease and psychiatric disorders
History of cognitive dysfunction or mental illness
Trial design
Design model
Parallel
Treatments tested in this trial
Intravenous Lipid Emulsion 20%
Drugpatients will receive 1.5 ml/kg bolus of intravenous lipid emulsion 20 % followed by 0.25 ml/kg/hr infusion over 30 minutes at the end of surgery
Control (placebo) group
Drugpatients will receive equal volume of normal saline at the end of surgery
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Group ILE (Intravenous lipid emulsion group)Experimental treatment 1 intervention
Group B: Group C (control group)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time for complete sensory and motor regression (min)
Time for complete sensory regression (min) (primary outcome) to be calculated from the time of ILEs administration (T0) until full sensation at S1 dermatomal level achieved Time for complete motor regression (min) (primary outcome) to be calculated from time of ILEs administration (T0) until Bromage score will be zero.
Time frame
6 hours after surgerySecondary outcomes
1
Time for two segment sensory regression (min)
the time for regression by two dermatomes compared with the dermatomal level assessed at finishing ILEs infusion (T0)
Time frame
6 hours after surgery2
Time to walk (min) without or with minimal assistance
the time from the ILE administration time (T0) till the patients first stand and walk.
Time frame
6 hours after surgery3
Time to Void (min)
the time from the ILE administration time (T0) till the patients first urinate.
Time frame
6 hours after surgery4
Time to be home-ready (min)
the time from the ILE administration time (T0) till the patients are ready for home discharge as defined by the modified post anaesthesia discharge scoring system.
Time frame
6 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov