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Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

NCT03426527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-09-11

No results posted yet for this study

Summary

Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.

Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics

Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects. Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical studies.

Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.

Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

Conditions

  • Tracheal Reconstruction

Interventions

DRUG

Levobupivacaine

Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine

DRUG

Levobupivacaine-Dexmedetomidine

Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine

OTHER

General Anaesthesia

Using propofol, fentanyl and atracurium

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Salwa MS Hayes, MD · Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-09-01
Completion
2018-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03426527 on ClinicalTrials.gov