Effect of Intravenous Dexmedetomidine on Patient Discomfort in Laparoscopic Cholecystectomy Under Spinal Anesthesia.

NCT04115449 | Unknown Phase 2 DMC

• 1 other identifier: TBRI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy (LC) has been routinely performed under general anesthesia despite the several disadvantages of general anesthesia compared to regional anesthesia. There are multiple reports that have been published regarding the feasibility of spinal anesthesia for LC associated with many problems such as referred shoulder pain secondary to intra-abdominal pneumoperitoneum; patient anxiety, pain, and discomfort; and inadequate sedation.The aim of our study is to prospectively observe the feasibility of using intravenous dexmedetomidine to abolish patient discomfort and shoulder pain, thus making the patient more comfortable without causing excessive sedation and respiratory depression.

Conditions

Shoulder Pain

Keywords

dexmedetomidine, shoulder pain, spinal anesthesia.

Outcome Measures

Primary Outcomes (1)

• Intraopertive shoulder pain

  The severity of pain will be graded as nil, mild, moderate and severe.

  60-90 minutes

Secondary Outcomes (1)

• Number of intraoperative hypoxic episodes

  60-90 minutes.

Other Outcomes (2)

• Number of intraopertive hypotensive episodes.

  60-90 minutes.

• Length of stay in PACU

  average 1 hour.

Study Arms (2)

Dexa group

EXPERIMENTAL

Spinal anaesthesia will be performed through the L3-4 interspace in the sitting position. After dural puncture with a 25 G Quincke needle, 3.5 ml of hyperbaric bupivacaine 0.5% solution with fentanyl 20 μg will be injected intrathecally. Than manintance dose of dexmedetomidine will be titrated from (0.2- 0.6 mcg /kg/ min) according to the patient discomfort. After turning the patient supine, level of sensory block will be assessed by the pinprick test using a 24-gauge hypodermic needle, while the motor block level will be assessed by the modified Bromage scale. Insufflation of gas will be done at the rate of 1.5 liters/min and the maximum abdominal pressure will be kept at 12 mmHg. Supplementary oxygen at 4 liters/min will be given with face mask.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

Normal Saline as a placebo will be infused over a period of ten minutes then spinal anaesthesia will be performed through the L3-4 interspace in the sitting position. After dural puncture with a 25 G Quincke needle, 3.5 ml of hyperbaric bupivacaine 0.5% solution with fentanyl 20 μg will be injected intrathecally. Then the placebo will be titrated according to patient discomfort. After turning the patient supine, level of sensory block will be assessed by the pinprick test using a 24-gauge hypodermic needle, while the motor block level will be assessed by the modified Bromage scale.Insufflation of gas will be done at the rate of 1.5 liters/min and the maximum abdominal pressure will be kept at 12 mmHg. Supplementary oxygen at 4 liters/min will be given with face mask.

Drug: normal saline

Interventions

Dexmedetomidine DRUG

Injection dexmedetomidine 1 mcg /kg will be infused over a period of ten minutes

Dexa group

normal saline DRUG

Normal Saline as a placebo will be infused over a period of ten minutes

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1-2.
• Patients undergoing elective laparoscopic Cholecystectomy with estimated pneumoperitoneum time of 60 to 90 min.

You may not qualify if:

• Pregnancy.
• Lactating women.
• Any contraindication to spinal anesthesia e.g. Bleeding diathesis, infection at the puncture site, patient on anticoagulants or preexisting neurological deficits in lower extremities.
• Patients on α2-adrenergic receptors antagonists, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
• Patients known allergic to bupivacaine or dexmedetomidine

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz research institute

Cairo, 02, Egypt

RECRUITING

Related Publications (1)

• Donmez T, Erdem VM, Uzman S, Yildirim D, Avaroglu H, Ferahman S, Sunamak O. Laparoscopic cholecystectomy under spinal-epidural anesthesia vs. general anaesthesia: a prospective randomised study. Ann Surg Treat Res. 2017 Mar;92(3):136-142. doi: 10.4174/astr.2017.92.3.136. Epub 2017 Feb 24.

  PMID: 28289667 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Moshira S Mohamed, MD

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

• Hend F Hassan, MD

  Theodor Bilharz Research Institute

  STUDY CHAIR

Central Study Contacts

Moshira S Mohamed, MD

CONTACT

202-1227206511; moshira.amer83@gmail.com

Hend F Hassan, MD

CONTACT

202-01005283829; hend10_fayed@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded randomized control study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Intensive care clinical researcher

Model Details: This is a prospective, randomized double blinded control study which will be conducted in department of anesthesia and surgical Intensive care unit at Theodor Bilharz Research Institute after approval by research ethics committee and patient informed consent. 40 patients will be enrolled in the study and divided into two groups either (Dexa group (D) or Control group (C).

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: November 15, 2019
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 month to 1 year

Locations

EG (1)