Can Head Position Improve Surgical Field During Ear Surgery?

NCT04095754 | Completed

• 1 other identifier: FMASU R 49/2019
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

Brief Summary

Middle ear surgeries utilizes microscope in a narrow field. They are better performed under controlled hypotension, to minimize bleeding and improve surgical field visualization and hence improve results.Head-up or anti-trendelenburg position influences intraoperative bleeding by generating regional ischaemia in sites elevated above the level of the heart. Also by augmenting the effect of vasodilators through pooling of blood in dilated veins.

Conditions

Intra-operative Bleeding

Outcome Measures

Primary Outcomes (2)

• Quality of surgical field.

  The surgeon, as well as the surgeon's assistant, will be asked to assess the surgical field using a 5-point scale: 1- no bleeding, 2- minimal bleeding, 3- bleeding easily controlled, 4- bleeding hindering work, 5- bleeding stops work.

  Immediately after surgery.

• Surgical position accessibility.

  The surgeon satisfaction concerning suitability of patient's position will be evaluated using a 5-point scale: 1- excellent, 2- good, 3- acceptable, 4- bad, 5- very bad.

  Immediately after surgery.

Secondary Outcomes (5)

• Total dexmedetomidine consumption.

  At the end of surgery

• Surgical time

  At the end of surgery

• Recovery time

  At the end of surgery

• Sedation Score

  on arrival to the PACU, then every 30 min for the first 2 hours after surgery

• Analgesia time

  first 12 hours after surgery

Study Arms (3)

Group I (control group)

OTHER

Patients will be positioned supine.

Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia

Group II

EXPERIMENTAL

patients will be positioned 10° anti-trendelenburg position.

Procedure: Head-Up Position; Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia

Group III

EXPERIMENTAL

patients will be positioned 20° anti-trendelenburg position.

Procedure: Head-Up Position; Drug: Dexmedetomidine; Drug: Induction and maintenance of anaesthesia

Interventions

Head-Up Position PROCEDURE

Anti-Trendelenburg Position

Also known as: Anti-Trendelenburg Position

Group II; Group III

Dexmedetomidine DRUG

Controlled hypotension: All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1

Also known as: controlled hypotension

Group I (control group); Group II; Group III

Induction and maintenance of anaesthesia DRUG

Induction of anaesthesia: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation. Maintenance:Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim.

Also known as: Anaesthetic drugs

Group I (control group); Group II; Group III

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II

You may not qualify if:

• Patients with uncontrolled hypertension, coronary artery disease or on beta blockers.
• Cerebrovascular insufficiency.
• Anaemia.
• End stage renal failure.
• Liver cirrhosis.
• Patients with coagulopathy or receiving drugs influencing blood coagulation.
• Pregnancy.
• Known sensitivity to any of the study drugs.
• Patients' refusal to participate in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams University Hospitals

Cairo, 11588, Egypt

Location

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Hypotension, Controlled; Neoadjuvant Therapy; Anesthetics

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia and Analgesia; Combined Modality Therapy; Therapeutics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 19, 2019
• Study Start: April 12, 2020
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the publication of the study

Locations

EG (2)