Spinal or Intravenous Dexmedetomidine in Ambulatory Surgery

NCT ID: NCT02282319

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2020-12-31

Brief Summary

The primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that sensory block will significantly be prolonged by dexmedetomidine administered by both the spinal and the intravenous route. The investigators do not expect a significant difference in motor block duration between intravenous or spinal administration. Secondary outcomes are micturition problems, duration of analgesia and the occurrence of side effects such as sedation and hypotension.

Detailed Description

The study is designed as a multicenter study and randomization and inclusion of patients will be performed in three hospitals. Each hospital has its own randomisation sequence and coordinating investigator who will be responsible for appointing blinded and unblinded participators in the study.

Patients scheduled for spinal anesthesia in ambulatory surgery will be randomized by sealed envelopes (computer generated sequence) into one of the following three study groups:

spinal chloroprocaine 40 mg with spinal dexmedetomidine (5mcg) spinal chloroprocaine 40 mg with intravenous dexmedetomidine ( 0.5 mcg/kg) spinal chloroprocaine 40 mg alone (control group)

All patients will receive the same amount of spinal solution, containing chloroprocaine 1% (4 ml) with dexmedetomidine (0.5 ml, 1 mcg/ml) or NaCl ( sodiumchloride) 0,9% (0.5 ml ) ( and 50 ml intravenous Nacl 0.9, containing dexmedetomidine (0.5 mcg/kg) or not depending on the study group. All solutions are prepared by an independent anesthesiologist and labelled as Intravenous study medication and spinal study medication. Spinal anesthesia and data registration will be done by a blinded anesthesist and/or study nurse on a data sheet designed for the study.

Spinal anesthesia is performed in the lateral decubitus at L3-L4 vertebral interspace and standard monitoring for this procedure is applied. Insufficient analgesia will be treated with sufentanil increments. Hypotension and bradycardia will be treated with ephedrine and atropine. Patients will be discharged when the block is regressed, there is no sedation or nausea and nrs scores of pain are below 4. Patients will be contacted by telephone after one week to evaluate any postoperative complaints.Micturition will receive a score based on bladder volumes measured by bladder scanning and subjective complaints . This score system was used in two of our former studies (1,2)

To calculate the power of this study, we used the mean L2 regression of a previous study after spinal chloroprocaine with its standard deviation (SD 20 min, mean 90 min) and compared it to a mean increase with 30 %. We calculated that we should include 7 patients in each group to obtain a power of 80%.

To be sure to detect a possible difference in discharge time as well, we calculated a sample size of 48 patients for each group to detect a 30-minute difference.

Statistical analysis will be done with ANOVA analysis , A kruskal-Wallis of Mann Whitney test depending on the distribution of the population and if the values are parametric or not. This will be done by spss.

Conditions

Surgery Ambulatory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

A chloro

spinal chloroprocaine 40 mg

Group Type: EXPERIMENTAL

spinal chloroprocaine 40 mg

Intervention Type: OTHER

spinal anesthesia with chloroprocaine 40 mg

B chloro+ spin dexdor

Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg

Group Type: EXPERIMENTAL

spinal dexmedetomidine 0.5 mcg

Intervention Type: DRUG

Administration of dexmedetomidine 0.5 mcg

spinal chloroprocaine 40 mg

Intervention Type: OTHER

spinal anesthesia with chloroprocaine 40 mg

C chloro + IV dexdor

Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg

Group Type: EXPERIMENTAL

spinal chloroprocaine 40 mg

Intervention Type: OTHER

spinal anesthesia with chloroprocaine 40 mg

IV dexmedetomidine 0.5 mcg/kg

Intervention Type: DRUG

intravenous administration of dexmedetomidine 0.5 mcg/kg

Interventions

spinal dexmedetomidine 0.5 mcg

Administration of dexmedetomidine 0.5 mcg

Intervention Type: DRUG

spinal chloroprocaine 40 mg

spinal anesthesia with chloroprocaine 40 mg

Intervention Type: OTHER

IV dexmedetomidine 0.5 mcg/kg

intravenous administration of dexmedetomidine 0.5 mcg/kg

Intervention Type: DRUG

Other Intervention Names

dexdor; ampres; dexdor

Eligibility Criteria

Inclusion Criteria

• ASA (American Society of Anesthesiologists) class 1 & 2,
• undergoing day-case knee arthroscopy

Exclusion Criteria

• micturition problems,
• neurological history or
• previous lower abdominal surgery with an abnormal micturition

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Dr M. B. Breebaart

dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

margaretha breebaart, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Marcel Vercauteren, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Antwerp, , Belgium

Sint Augustinus

Wilrijk, , Belgium

Countries

Belgium

References

Breebaart MB, Vercauteren MP, Hoffmann VL, Adriaensen HA. Urinary bladder scanning after day-case arthroscopy under spinal anaesthesia: comparison between lidocaine, ropivacaine, and levobupivacaine. Br J Anaesth. 2003 Mar;90(3):309-13. doi: 10.1093/bja/aeg078.

Reference Type: BACKGROUND

PMID: 12594142 (View on PubMed)

Breebaart MB, Teune A, Sermeus LA, Vercauteren MP. Intrathecal chloroprocaine vs. lidocaine in day-case surgery: recovery, discharge and effect of pre-hydration on micturition. Acta Anaesthesiol Scand. 2014 Feb;58(2):206-13. doi: 10.1111/aas.12247.

Reference Type: BACKGROUND

PMID: 24563922 (View on PubMed)

Other Identifiers

13/35/334

Identifier Type: -

Identifier Source: org_study_id