Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

NCT03426527 | Completed DMC

• 1 other identifier: R/17.09.19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cumulative postoperative opioid consumption

  Total postoperative opioid consumption

  For 24 hours after surgery

Secondary Outcomes (8)

• Systolic blood pressure

  Before and for 6 hours after start of anaesthesia

• Diastolic blood pressure

  Before and for 6 hours after start of anaesthesia

• Heart rate

  Before and for 6 hours after start of anaesthesia

• Peripheral oxygen saturation

  Before and for 6 hours after start of anaesthesia

• End-tidal carbon dioxide tension

  Before and for 6 hours after start of anaesthesia

Study Arms (2)

Levobupivacaine

PLACEBO COMPARATOR

Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia

Drug: Levobupivacaine; Other: General Anaesthesia

Levobupivacaine-Dexmedetomidine

ACTIVE COMPARATOR

Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia

Drug: Levobupivacaine-Dexmedetomidine; Other: General Anaesthesia

Interventions

Levobupivacaine DRUG

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

Levobupivacaine

Levobupivacaine-Dexmedetomidine DRUG

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

Levobupivacaine-Dexmedetomidine

General Anaesthesia OTHER

Using propofol, fentanyl and atracurium

Levobupivacaine; Levobupivacaine-Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status I or II.

You may not qualify if:

• History of allergy to the drugs used
• Coagulation disorders
• Pregnancy
• Postpartum period.
• Lactating females
• Local sepsis

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Levobupivacaine; Anesthesia, General

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia; Anesthesia and Analgesia

Study Officials

• Salwa MS Hayes, MD

  Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 8, 2018
• Study Start: March 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

EG (1)